FDA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Boston Scientific Recalls Imager II Angiographic Catheters
2026-09-29 | FDA | cdrh_news | !!! HIGH
FDA posted a recall notice for Boston Scientific Imager II Angiographic Catheters. The company is removing affected devices due to potential catheter tip separation, which may cause serious patient harm. Healthcare facilities should immediately identify, quarantine, and return affected lots and follow Boston Scientific's removal instructions.
Tags: recall, angiographic_catheter, boston_scientific, safety_alert
Becton Dickinson Corrects Convenience Kits and Procedure Trays with Recalled Sodium Chloride Ampules
2026-09-29 | FDA | cdrh_news | !!! HIGH
FDA posted Becton Dickinson's correction for convenience kits and procedure trays containing recalled sodium chloride ampules. Healthcare facilities that received affected BD kits or trays should identify, quarantine, and remove the recalled ampules before use, and follow BD’s correction notice. The issue involves potential safety risks from the sodium chloride ampules; affected components should not be used.
Tags: convenience_kit, sodium_chloride_ampules, recall_correction, becton_dickinson, cdrh
FDA Announces Abiomed Recall to Remove Automated Impella Heart Pump Controllers
2026-09-29 | FDA | cdrh_news | !!! HIGH
FDA has posted a recall notice stating Abiomed is removing Automated Impella Controllers used with Impella heart pumps. This action affects healthcare facilities that use these controllers for mechanical circulatory support. Affected users should immediately identify, quarantine, and return or replace the recalled controllers according to Abiomed’s instructions and report adverse events to FDA.
Tags: heart_pump_controller, recall, abiomed_impella
Class I Recall Z-3151-2026: AVID Medical Haylard 18G Single Shot EPI Tray Kit DPGE002-02
2026-09-23 | FDA | recall_class1 | !!! HIGH
FDA posted a Class I recall (Z-3151-2026) by AVID Medical, Inc. for 1,640 Haylard 18G Single Shot EPI Tray kits, model DPGE002-02. The kits may contain Sodium Chloride ampules subject to a separate Spectra Medical recall, creating potential product quality and sterility risks. Healthcare providers should immediately quarantine and stop using affected kits, verify inventory, and follow AVID Medical's recall instructions.
Tags: class_i_recall, sterility_issue, sodium_chloride_ampules, avid_medical, fda_recall
Class I Recall: Medline Convenience Kits DYKM1000B and DYKM218 Due to Aspergillus Contamination
2026-09-23 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall (Z-3125-2026) by Medline Industries, LP affecting 2,718 Medline Convenience Kits, catalog numbers DYKM1000B and DYKM218. The kits contain certain lots of sterile applicators that may allow growth of Aspergillus penicillioides under certain environmental conditions, posing a potential fungal infection risk. Healthcare facilities and users should identify and quarantine affected kits and follow Medline's recall return or disposal instructions.
Tags: class_i_recall, fungal_contamination, sterile_applicators, medline_industries
Class I Recall: Nova Biomedical StatStrip Glucose/B-Ketone Meter Model 63910 for Barcode Patient ID Retention Issue
2026-09-23 | FDA | recall_class1 | !!! HIGH
FDA classified this as a Class I recall of Nova Biomedical Corporation's StatStrip Glucose/B-Ketone Meter, model 63910. A software synchronization/timing issue in the barcode scanning and patient data processing component can intermittently retain a previously scanned barcode, including patient ID, creating a risk of patient/sample mix-up and incorrect results. The recall covers 8,939 units. Facilities should identify and quarantine affected meters, follow Nova Biomedical’s recall instructions, and verify patient barcode/ID before testing.
Tags: class_i_recall, glucose_test_system, barcode_software_issue, patient_id_mixup, nova_biomedical
Class I Recall: Abiomed Automated Impella Controller (AIC) Due to Purge Cassette Recognition Failure
2026-09-23 | FDA | recall_class1 | !!! HIGH
The FDA has posted a Class I recall (Z-3148-2026) for Abiomed, Inc.'s Automated Impella Controller (AIC). The recall is due to potential purge cassette recognition issues caused by failure of the purge flag component of the purge pressure sensor assembly, which may lead to therapy interruption or patient harm. The recall covers 5,232 units (3,733 U.S.; 1,499 OUS). Healthcare facilities should immediately identify and quarantine affected AIC devices and follow Abiomed's recall instructions for correction or return.
Tags: class_i_recall, abiomed, impella_controller, purge_cassette_failure
Class I Recall: AVID Medical Haylard UNIV IMAGING BIOPSY TRUCUSTOM Kit VARV042-03 (340 Kits)
2026-09-23 | FDA | recall_class1 | !!! HIGH
AVID Medical, Inc. is recalling 340 kits of the Haylard UNIV IMAGING BIOPSY TRUCUSTOM (kit VARV042-03) because the kits contain Sodium Chloride ampules subject to a Spectra Medical recall due to potential product quality and sterility issues. This is a Class I recall, the most serious type, indicating a reasonable probability of serious health consequences such as infection. Affected kits should be immediately quarantined, removed from use, and returned or disposed of according to AVID Medical's instructions.
Tags: class_i_recall, sterility_issue, biopsy_kit, sodium_chloride_ampules, avid_medical
Nova Biomedical StatStrip Glucose Hospital Meter Class I Recall Over Barcode Retention Software Issue
2026-09-23 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall (Z-3128-2026) for Nova Biomedical Corporation’s StatStrip Glucose Hospital Meter System, Model 63685. A software synchronization/timing issue in barcode scanning and patient data processing can intermittently retain a previously scanned barcode, including patient identifiers, creating a risk that glucose results are linked to the wrong patient and leading to inappropriate treatment. The recall covers 20,616 units. Users should immediately follow Nova Biomedical’s recall instructions, verify patient identity manually before each test or clear the prior barcode, and quarantine affected devices until correction.
Tags: class_i_recall, glucose_test_system, barcode_software_error, nova_biomedical
Class I Recall: Medline Anesthesia L&D A-Line Set Convenience Kit (Catalog DY) Due to Aspergillus Contamination
2026-09-23 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall (Z-3121-2026) for Medline Industries, LP's Medline Convenience Kits, specifically the KIT ANESTHESIA L&D A-LINE SET, Catalog Number DY. The recall covers 12 kits containing certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides, a fungal hazard. Healthcare facilities should immediately quarantine and stop using affected kits and follow Medline's recall instructions for return or replacement.
Tags: class_i_recall, fungal_contamination, sterile_applicators, convenience_kits
Class I Recall Z-3149-2026: Abiomed Impella Optical Controller Purge Cassette Recognition Failure
2026-09-23 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has initiated a Class I recall of 1,422 Impella Optical Controller units (487 in the U.S., 935 outside the U.S.) because the purge flag component of the purge pressure sensor assembly may fail, leading to purge cassette recognition issues. This can compromise purge pressure monitoring and potentially cause device malfunction or patient harm. Affected facilities should immediately identify and quarantine affected controllers and contact Abiomed for correction or replacement.
Tags: class_i_recall, abiomed_impella, purge_system_failure
Class I Recall Z-3126-2026: Medline Convenience Kits DYNDH1193 and DYNDH14 Aspergillus Risk
2026-09-23 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 1,100 Medline Convenience Kits (catalog numbers DYNDH1193 and DYNDH14) because certain lots of sterile applicators may be contaminated with Aspergillus penicillioides, a fungus that can cause serious infections, particularly in vulnerable patients. This is a Class I recall, the most serious type, indicating use of affected kits may cause serious health consequences or death. Healthcare facilities and distributors should immediately locate and quarantine affected kits, stop use, and follow Medline’s recall instructions.
Tags: class_i_recall, aspergillus_contamination, sterile_applicators, medline_convenience_kits
Class I Recall: Medline Convenience Kits OPEN HEART ADULT (CDS840396Y) Due to Fungal Contamination
2026-09-23 | FDA | recall_class1 | !!! HIGH
FDA classified Medline Industries LP’s recall of Medline Convenience Kits, OPEN HEART ADULT, catalog CDS840396Y, as Class I. The kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides under certain environmental conditions, posing a serious infection risk. The recall covers 489 kits. Users should immediately quarantine affected kits, discontinue use, and follow Medline’s recall instructions.
Tags: class_i_recall, fungal_contamination, sterile_applicators
Medline Class I Recall of Convenience Kits (DYNDB3086D/DYNDB31) Over Aspergillus Contamination
2026-09-23 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall (Z-3127-2026) by Medline Industries, LP affecting 47,848 Medline Convenience Kits, including catalog numbers DYNDB3086D and DYNDB31. The kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides under certain environmental conditions, posing a serious fungal infection risk. Distribution details were not specified in the FDA posting. Users should immediately quarantine affected kits and follow Medline’s recall instructions.
Tags: class_i_recall, aspergillus_contamination, sterile_applicator, medline
FDA Class I Recall Z-3150-2026: Abiomed Impella Optical, Automated Controllers and Connect Package
2026-09-23 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall (Z-3150-2026) by Abiomed, Inc. affecting the Impella Optical Controller, Automated Impella Controller, and Impella Connect Package. The recall is due to potential purge cassette recognition issues caused by failure of the purge flag component of the purge pressure sensor assembly, which may compromise purge flow and patient safety. A total of 4,100 units are affected, including 2,785 in the U.S. and 1,315 outside the U.S. Users should follow Abiomed's recall instructions, identify affected devices, and arrange for replacement or correction.
Tags: class_i_recall, abiomed_impella, purge_cassette, medical_device_safety
Class I Recall: AVID Medical Haylard BASIC BIOPSY TRAY Kit PM415 (Z-3153-2026)
2026-09-23 | FDA | recall_class1 | !!! HIGH
AVID Medical, Inc. is recalling 240 Haylard BASIC BIOPSY TRAY kits, model/item number PM415, under FDA recall Z-3153-2026. The recall is due to potential product quality and sterility issues because the kits contain Sodium Chloride ampules subject to a separate Spectra Medical recall. Users should immediately quarantine and discontinue use of affected kits and follow the recalling firm’s instructions.
Tags: class_i_recall, sterility_issue, biopsy_tray
FDA Class I Recall: Medline Convenience Kits - Sterile Applicators May Have Aspergillus penicillioides (Z-3124-2026)
2026-09-23 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 10,407 Medline Convenience Kits, including catalog number ACC010308A, because certain lots of sterile applicators may be contaminated with Aspergillus penicillioides and cause serious fungal infection. This is a Class I recall, the most serious type, indicating a reasonable probability of serious adverse health consequences or death. Facilities should immediately identify, quarantine, and stop using affected kits, then follow Medline's recall instructions for return or disposal.
Tags: class_i_recall, medline_industries, aspergillus_penicillioides, sterile_applicators, fungal_contamination
Bard Recalls Power-Trialysis Short-Term Straight Dialysis Catheter (REF 5605150), Class I Recall Z-2984-2026
2026-09-23 | FDA | recall_class1 | !!! HIGH
Bard Access Systems, Inc. is conducting a Class I recall (Z-2984-2026) of the Power-Trialysis Short-Term Straight Dialysis Catheter, REF 5605150, involving 149,521 units. This is a downstream recall of Class I recall RES 98777, indicating the same serious health risk as the original action. Users should immediately identify and quarantine affected inventory and follow the firm’s recall notification for return or correction.
Tags: class_i_recall, dialysis_catheter, downstream_recall
Class I Recall: AVID Medical Halyard IV START KIT NON-STERILE REF KRIV26-02 Due to Aspergillus Contamination
2026-09-23 | FDA | recall_class1 | !!! HIGH
AVID Medical, Inc. is recalling 288 units of the Halyard IV START KIT NON-STERILE (REF KRIV26-02), a convenience kit containing BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators contaminated with Aspergillus penicillioides. This Class I recall (FDA #Z-3108-2026) poses a risk of serious infection, particularly in vulnerable patients. Healthcare facilities should immediately locate and quarantine affected kits, discontinue use, and follow the recalling firm's return or destruction instructions.
Tags: class_i_recall, fda_recall, aspergillus_contamination, convenience_kit, avid_medical
Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets
2026-09-22 | FDA | cdrh_news | !!! HIGH
FDA announced that CooperSurgical is removing INCA Infant Nasal CPAP Sets, which are used with ventilators for infant respiratory support. The recall affects healthcare facilities and neonatal patients using these CPAP sets. Facilities should immediately identify and quarantine affected products, discontinue use, and follow CooperSurgical's recall instructions for return or replacement.
Tags: recall, ventilator, neonatal_cpap
AVID Medical Convenience Kit Correction: Huons Sodium Chloride Ampules
2026-09-22 | FDA | cdrh_news | !!! HIGH
FDA CDRH posted a correction notice from AVID Medical concerning convenience kits that contain Huons Sodium Chloride Ampules. Healthcare providers and distributors who received these AVID Medical kits should identify and quarantine affected inventory and follow the company’s correction instructions. No separate deadline is specified in the alert; users should monitor the FDA page and AVID Medical communications for updates.
Tags: medical_device_correction, convenience_kits, sodium_chloride_ampules
Spectra Medical Recalls Sodium Chloride Injection USP Ampules Used for Flushing
2026-09-22 | FDA | cdrh_news | !!! HIGH
FDA posted a recall notice for Spectra Medical’s Sodium Chloride Injection USP ampules, which are used as sodium chloride flushes. Healthcare facilities and providers should immediately identify and quarantine affected ampules and follow Spectra Medical’s return or disposal instructions. The recall is due to a lack of sterility assurance, which may lead to serious infections.
Tags: recall, sterility_assurance, sodium_chloride_flush
FDA CDRH Town Hall on Biocompatibility Risk Assessment – September 9, 2026
2026-09-22 | FDA | cdrh_news | !! MEDIUM
FDA’s Center for Devices and Radiological Health (CDRH) announced a town hall on biocompatibility risk assessment scheduled for September 9, 2026. The event is intended for medical device manufacturers, regulatory affairs professionals, and biocompatibility specialists. Stakeholders should attend or submit questions to gain insight into CDRH’s current expectations and best practices for biocompatibility evaluation.
Tags: biocompatibility, risk_assessment, cdrh, town_hall, medical_devices
Class I Recall: Medical Action Single Shot Epidural Kits (REF 59553) Due to Compromised Sterility
2026-09-16 | FDA | recall_class1 | !!! HIGH
FDA has classified this as a Class I recall. Medical Action Industries, Inc. is recalling 3,606 Single Shot Epidural 20/Cs kits (REF: 59553 and related REF) because they contain Sodium Chloride ampules subject to another recall due to potentially compromised sterility, posing a serious infection risk. Affected kits should be immediately quarantined, not used, and returned per the firm's recall instructions.
Tags: class_i_recall, epidural_kit, sterility
Medical Action Industries Recalls Epidural/Pain Kit REF 82465 Due to Potential Sterility Compromise
2026-09-16 | FDA | recall_class1 | !!! HIGH
Medical Action Industries, Inc. is recalling its Kit: Epidural/Pain TQC 20/Cs, REF 82465, because the kits contain sodium chloride injection ampules subject to another recall for potentially compromised sterility. This Class I recall covers 1,960 kits and poses a risk of serious infection if compromised components are used. Healthcare providers should immediately quarantine and discontinue use of affected kits and follow the firm’s recall instructions.
Tags: class_i_recall, compromised_sterility, epidural_pain_kit
Class I Recall: Given Imaging Bravo CF Capsule Delivery Device FGS-0635 (Z-3090-2026)
2026-09-16 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall (Z-3090-2026) for Given Imaging Ltd.’s Bravo CF capsule delivery device, 5-pack, product number FGS-0635. The capsule may fail to attach to the esophagus or detach from the delivery device, creating risks of aspiration/inhalation, esophageal perforation, airway obstruction, and hemorrhage/blood loss. The recall involves 127,416 units. Healthcare providers should immediately quarantine affected devices and follow Given Imaging’s recall instructions.
Tags: class_i_recall, medical_device_recall, capsule_delivery_device, patient_safety
FDA Announces Medtronic and Given Imaging Recall of Esophageal pH Monitoring Capsule Delivery Device
2026-09-15 | FDA | cdrh_news | !!! HIGH
The FDA posted a recall notice for the esophageal pH monitoring capsule delivery device manufactured by Medtronic and Given Imaging. This device is used to deliver a pH capsule for gastroesophageal reflux monitoring, and the recall addresses delivery system safety concerns. Healthcare providers should identify and quarantine affected devices, stop use, and follow the manufacturers' instructions for return, replacement, or correction. Regulatory affairs professionals should verify impacted lot numbers and report adverse events to the FDA.
Tags: medical_device_recall, esophageal_ph_monitoring, medtronic, given_imaging, cdrh_news
Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
2026-09-15 | FDA | cdrh_news | !!! HIGH
FDA CDRH posted a notice that Medical Action Industries issued a correction for epidural kits containing lidocaine ampules manufactured by Spectra Medical Devices. Healthcare facilities, distributors, and providers with affected kits should immediately identify and quarantine the products and follow the manufacturer's recall/correction instructions. The notice appears under FDA medical device recalls and early alerts; affected parties should monitor the FDA listing for lot-specific details and report any adverse events.
Tags: medical_device_recall, epidural_kits, lidocaine_ampules, cdrh_news
Recall: NOxBOX LTD NOxBOXi Nitric Oxide Delivery System (NOXBOX-I) Due to Irregular Oxygen Readings
2026-09-14 | FDA | Safety Communication | !!! HIGH
FDA has posted recall Z-3306-2026 for NOXBOX LTD's NOxBOXi Nitric Oxide Delivery System, model NOXBOX-I, due to a manufacturing issue affecting certain oxygen sensors that may cause irregular oxygen readings. Affected devices could provide inaccurate oxygen monitoring, potentially leading to hypoxic or hyperoxic gas delivery. Providers should identify affected units, follow manufacturer instructions for discontinuation or correction, and contact the manufacturer.
Tags: fda_recall, nitric_oxide_delivery_system, oxygen_sensor
Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Leads
2026-09-08 | FDA | cdrh_news | !! MEDIUM
CDRH News
GE HealthCare Updates Use Instructions for Portrait Core Services Software Correction
2026-09-08 | FDA | cdrh_news | !! MEDIUM
FDA announced a monitoring system correction by GE HealthCare for its Portrait Core Services Software. The company is updating use instructions to address potential operational issues and ensure safe use. Healthcare providers using this software should review the corrected instructions and implement changes in their monitoring workflows promptly.
Tags: ge_healthcare, software_correction, use_instructions, monitoring_system
Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators
2026-09-08 | FDA | cdrh_news | !!! HIGH
FDA is alerting stakeholders that Medline Industries has issued a correction for convenience kits containing BD ChloraPrep applicators, which are affected by a related BD applicator recall. Healthcare facilities and distributors that received these kits should identify affected lots and follow Medline's instructions for quarantine, return, or disposal. Immediate action is recommended to prevent use of affected kits.
Tags: medical_device_recall, convenience_kits, chloraprep, antiseptic_applicator, fda_cdrh
Medline Recalls Neonatal and Infant Heated Wire Breathing Circuits
2026-09-08 | FDA | cdrh_news | !!! HIGH
FDA CDRH announced that Medline is removing/recalling neonatal and infant heated wire breathing circuits. This action affects healthcare facilities using these Medline circuits for neonatal and infant respiratory support. Affected users should identify the recalled products, stop use, quarantine them, and follow Medline’s recall instructions.
Tags: recall, breathing_circuit, neonatal, infant, medline, medical_device_safety
Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
2026-09-08 | FDA | cdrh_news | !! MEDIUM
CDRH News
Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
2026-09-08 | FDA | cdrh_news | !! MEDIUM
CDRH News
Class I Recall: BMC/REACTHEALTH Luna G3 APAP (REF LG 3600) – 20,160 Units, 2024 Warehouse Rework
2026-08-26 | FDA | recall_class1 | !!! HIGH
The FDA posted a Class I recall by BMC Medical Co., Ltd. covering 20,160 units of the BMC/REACTHEALTH Luna G3 APAP (REF LG 3600). The recall reason is retroactive reporting of 2024 rework performed at the 3B/React Health warehouse; Class I status indicates a reasonable probability of serious adverse health consequences or death. Users, healthcare facilities, and distributors should identify and quarantine affected devices and follow the manufacturer's recall instructions.
Tags: class_i_recall, cpap_device, rework_reporting
Class I Recall: Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus (Z-2978-2026)
2026-08-26 | FDA | recall_class1 | !!! HIGH
The FDA has classified Boston Scientific Corporation's recall of the ENROUTE Transcarotid Neuroprotection System Plus as Class I due to potential arterial sheath tip separation or partial tip separation during use, which may lead to serious adverse events such as vessel injury, thrombosis, or stroke. The recall affects 49,229 units under recall number Z-2978-2026. Healthcare providers should immediately identify and quarantine affected inventory and follow Boston Scientific's recall instructions.
Tags: class_i_recall, boston_scientific, neuroprotection_system, arterial_sheath_tip_separation
Class I Recall Z-2872-2026: Bard BD Powered Driver Needle Kit 15mm x 15Ga REF D015151NK
2026-08-26 | FDA | recall_class1 | !!! HIGH
FDA classified this Bard Access Systems, Inc. action as a Class I recall (Z-2872-2026) affecting the BD Needle Kit for Powered Driver 15mm x 15Ga, REF D015151NK. The recall covers 80,200 intraosseous needle kits used when intravenous access is difficult or impossible in emergent, urgent, or medically necessary situations; after placement, users may experience difficulty with the device. Customers should immediately quarantine affected inventory and follow the manufacturer’s recall instructions.
Tags: class_i_recall, intraosseous_needle_kit, bard_access_systems
Early Alert: Portrait Mobile Monitoring Software Issue from GE HealthCare
2026-08-25 | FDA | cdrh_news | !! MEDIUM
CDRH News
Key Considerations for the Development and Use of Digitally Derived Measures for Clinical Investigations, FDA Paper
2026-08-25 | FDA | cdrh_news | !! MEDIUM
CDRH News
Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Com
2026-08-25 | FDA | cdrh_news | !! MEDIUM
CDRH News
Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback
2026-08-18 | FDA | cdrh_news | !! MEDIUM
CDRH News
Intraosseous Needle Set Recall: Becton Dickinson Removes Certain Intraosseous Vascular Access System Needle Sets
2026-08-18 | FDA | cdrh_news | !! MEDIUM
CDRH News
FDA Announces Baxter Duo-Vent Intravascular Administration Set Recall
2026-08-18 | FDA | cdrh_news | !!! HIGH
FDA issued a recall notice for Baxter Duo-Vent Solution Sets used in intravascular administration. Health care providers should immediately identify and quarantine affected lots, stop using the devices, and follow Baxter's return or disposal instructions. Patients who may have been exposed should be monitored, and adverse events should be reported to FDA.
Tags: recall, intravascular_administration_set, baxter, safety_alert
Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Compon
2026-08-18 | FDA | cdrh_news | !! MEDIUM
CDRH News
Olympus POWERSEAL 5mm 23cm Curved Jaw Sealer & Divider Recalled for Outer Box Labeling as 37-cm Device
2026-08-18 | FDA | Safety Communication | !!! HIGH
FDA has posted device recall Z-3035-2026 for Olympus Corporation of the Americas' POWERSEAL 5 mm diameter, 23 cm long curved jaw sealer and divider, double action. The recall is due to a labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Providers should check inventory and follow recall instructions to avoid potential device selection errors during procedures.
Tags: fda_recall, labeling_deficiency, electrosurgical_device, olympus, medical_device_safety
Class I Recall: AVID Medical Halyard Kits with Recalled Medline Namic Angiographic Star Off Manifolds
2026-08-12 | FDA | recall_class1 | !!! HIGH
AVID Medical, Inc. is recalling 5,168 Halyard convenience kits because they contain Medline Namic Angiographic Star Off Handle Manifolds that were recalled due to particulates in the fluid path. Particulate contamination in the angiographic manifold fluid path may present a serious risk of embolic or vascular events if used. Users should immediately locate, quarantine, and stop using affected kits, and follow recall instructions from AVID Medical or Medline.
Tags: class_i_recall, particulate_contamination, angiographic_manifold
Class I Recall: Boston Scientific INFINION CX Lead Kit (SC-2317-50) – Lead Fracture Risk
2026-08-12 | FDA | recall_class1 | !!! HIGH
FDA has posted Class I recall #Z-2879-2026 for Boston Scientific Neuromodulation Corporation’s INFINION CX Lead Kit, 50 cm (Model SC-2317-50, Material M365SC2317500). The recall covers 1,079 units because stress at the anchor site may cause high impedance or lead fractures, potentially leading to inadequate spinal cord stimulation or additional intervention. Facilities and users should identify and quarantine affected leads and follow Boston Scientific’s recall instructions for return or replacement.
Tags: class_i_recall, spinal_cord_stimulation, lead_fracture
Class I Recall Z-2798-2026: AVID Medical Halyard Kits with Recalled Medline Namic Angiographic Manifolds
2026-08-12 | FDA | recall_class1 | !!! HIGH
AVID Medical, Inc. is recalling 5,168 Halyard convenience kits because they contain Medline Namic Angiographic Star Off Handle Manifolds recalled due to particulates in the fluid path. This is a Class I recall, indicating a reasonable probability of serious adverse health consequences or death. Affected users should quarantine the kits and follow AVID Medical/Medline recall instructions for return or replacement.
Tags: class_i_recall, particulate_contamination, angiographic_manifold, convenience_kits
Hamilton Medical Recalls Breathing Circuit Set: FDA Announces Removal
2026-08-11 | FDA | cdrh_news | !!! HIGH
The FDA announced that Hamilton Medical is recalling its Breathing Circuit Set. Healthcare facilities using these circuits should immediately stop use and return affected products. The recall addresses a potential issue that could compromise ventilation therapy; specific lot numbers and corrective actions are outlined in the company's notification.
Tags: medical_device_recall, breathing_circuit, hamilton_medical, ventilation, safety_alert
Baxter Novum IQ Syringe Pump Recall: Software Issue in Volume/Time Multi-Syringe Infusion (Z-3065-2026)
2026-08-11 | FDA | Safety Communication | !!! HIGH
The FDA posted a recall (Z-3065-2026) for the Baxter Healthcare Corporation Novum IQ Syringe Pump, Model 40800BAXUS. A software issue may occur during Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains, potentially causing infusion interruption or delay. Healthcare providers should follow Baxter’s recall instructions, identify affected devices, and implement required corrections or mitigations.
Tags: device_recall, infusion_pump, software_issue
Device Recall: Baxter Healthcare Corporation - Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
2026-08-11 | FDA | Safety Communication | !! MEDIUM
Recall Z-3066-2026: A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Fresenius 5008X Standard HD Pre-Flush Blood Tubing Set (03-5110-6) Recall: Blood Leak Risk
2026-08-10 | FDA | Safety Communication | !!! HIGH
FDA recall Z-3084-2026 affects the Fresenius Medical Care Renal Therapies Group 5008X Standard HD Pre-Flush Standard Blood Tubing Set, part number 03-5110-6. The connection between the Arterial Alpha Clip and the main line or pump segment has a heightened probability of blood leak, which may cause blood loss and hypovolemia during hemodialysis. Providers should identify and quarantine affected sets, follow recall instructions, and monitor patients for signs of blood loss.
Tags: device_recall, fda_safety, hemodialysis_tubing, blood_leak
FDA Recall: Fresenius 5008X HD/HDF Standard Blood Tubing Set (P/N 03-5300-3) Leak Risk
2026-08-10 | FDA | Safety Communication | !!! HIGH
The FDA has posted recall Z-3085-2026 for the Fresenius Medical Care Renal Therapies Group 5008X HD/HDF Standard Blood Tubing Set, part number 03-5300-3, due to a heightened probability of blood leakage at the connection between the Arterial Alpha Clip and the main line or pump segment. A leak during hemodialysis or hemodiafiltration may lead to blood loss and hypovolemia. Healthcare providers should stop use and quarantine affected sets, contact Fresenius for return/replacement, and monitor patients for signs of blood loss if a leak was suspected.
Tags: fda_recall, hemodialysis_tubing_set, blood_loss_hypovolemia
Fresenius 5008X HD/HDF with CLiC Blood Tubing Set (Part 03-5300-3C) Recalled Due to Blood Leak Risk
2026-08-10 | FDA | Safety Communication | !!! HIGH
The FDA has posted recall Z-3086-2026 for Fresenius Medical Care Renal Therapies Group, LLC's 5008X HD/HDF with CLiC Blood Tubing Set, part number 03-5300-3C. The connection between the Arterial Alpha Clip and the main line or pump segment has a heightened probability of blood leak, which may lead to blood loss and hypovolemia during treatment. Healthcare providers should identify and quarantine affected tubing sets and follow Fresenius Medical Care's recall instructions.
Tags: fda_recall, hemodialysis, blood_leak_risk, fresenius_medical_care
Fresenius 5008X HD/HDF with Twister Blood Tubing Set (Part 03-5350-8) Recalled Due to Blood Leak Risk
2026-08-10 | FDA | Safety Communication | !!! HIGH
FDA posted recall Z-3087-2026 for Fresenius Medical Care Renal Therapies Group's 5008X HD/HDF with Twister Blood Tubing Set, part number 03-5350-8. The device has a heightened probability of blood leak at the connection between the Arterial Alpha Clip and the main line or pump segment, which may cause blood loss and hypovolemia during treatment. Affected facilities should identify and quarantine the product, and users should follow the manufacturer's recall instructions and monitor for leaks.
Tags: device_recall, fresenius_medical_care, blood_tubing_set, hemodialysis, fda_safety
ResMed Astral 100/150 Ventilator Class I Recall: Supercapacitor Leak May Stop Therapy
2026-08-05 | FDA | recall_class1 | !!! HIGH
FDA has classified ResMed’s recall of the Astral 100 and Astral 150 ventilators as a Class I recall, the most serious type, because electrolyte leakage from a supercapacitor on the printed circuit board assembly can damage the charger chip and force the device into a fail-safe state, interrupting ventilation therapy. This failure may cause serious patient harm or death. The recall covers 168,069 units distributed globally. Users must follow ResMed’s instructions to monitor for alarms and contact the company for a replacement if the device is affected.
Tags: class_i_recall, ventilator, resmed, supercapacitor_leakage, patient_safety
Class I Recall of Medical Action Industries Angiography Pack (REF NCAG62I) Due to Particulate in Fluid Path
2026-08-05 | FDA | recall_class1 | !!! HIGH
Medical Action Industries, Inc. has initiated a Class I recall of its Pack Angiography NCMC 3/Cs BANNER (REF NCAG62I) because the included Medline Namic manifolds may contain particulate in the fluid path. If particles enter the bloodstream during cardiovascular procedures, they could cause serious adverse health events. The recall involves 657 kits distributed across the U.S.; healthcare facilities should immediately stop using the affected product, quarantine remaining inventory, and follow return instructions.
Tags: class_i_recall, particulate_contamination, angiography_pack, medical_action_industries, vascular_procedure
Medline Recalls Convenience Kits with Huons Lidocaine and Bupivacaine Injection Due to Incorrect Drug Concentration
2026-08-04 | FDA | cdrh_news | !!! HIGH
Medline Industries has issued a correction for convenience kits containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection due to a labeling error that misstates the drug concentration. Affected kits were distributed to healthcare facilities nationwide. Users should immediately quarantine and return any impacted kits to Medline and avoid using the product until corrected replacements are provided.
Tags: convenience_kit_recall, lidocaine_bupivacaine, medication_labeling_error, cdrh, medical_device_correction
Medical Action Industries Corrects Convenience Kits with Recalled Namic Manifolds
2026-08-04 | FDA | cdrh_news | !! MEDIUM
Medical Action Industries has issued a correction for certain convenience kits that contain Namic manifolds previously recalled due to potential sterility or performance issues. Healthcare providers and facilities using these kits should immediately identify and quarantine affected products, and follow the company’s instructions for return or replacement. The FDA notice alerts users to check inventory and stop using impacted kit lots to prevent patient safety risks.
Tags: recall, convenience_kit, namic_manifold, correction, sterility_risk
Argon Medical Issues Correction for Convenience Kits Containing Spectra Lidocaine Ampules
2026-08-04 | FDA | cdrh_news | !! MEDIUM
Argon Medical has announced a voluntary correction for convenience kits that include Spectra Medical Device Lidocaine Ampules, due to a potential issue with the ampules. Healthcare providers using these kits should immediately quarantine and stop using the affected products, and follow Argon Medical’s instructions for return or disposal. The FDA is sharing this CDRH news update to raise awareness and protect patient safety.
Tags: convenience_kit, argon_medical, lidocaine_ampules, field_correction, cdrh_news
FDA Posts Town Hall Slides & Transcript on Human Factors Info in Marketing Submissions Final Guidance (July 2026)
2026-08-04 | FDA | cdrh_news | !! MEDIUM
The CDRH published the presentation, slides, and transcript from the July 22, 2026 town hall discussing the final guidance on human factors information in medical device marketing submissions. The materials clarify how manufacturers should incorporate usability engineering data in 510(k), PMA, and De Novo applications. Review is recommended for regulatory and R&D teams to align future submissions with current FDA expectations.
Tags: human_factors, marketing_submission, town_hall, final_guidance
Recall Z-2872-2026: Bard BD Needle Kits for Powered Driver (15mm/25mm, 15Ga) Obturator Locking Issue
2026-07-30 | FDA | Safety Communication | !!! HIGH
FDA posted recall Z-2872-2026 affecting Bard Access Systems BD Needle Kits for Powered Driver, specifically 15mm x 15Ga (REF D015151NK) and 25mm x 15Ga (REF D01525). These intraosseous needle sets may have an obturator that locks after placement, making it difficult or impossible to remove during emergent or urgent vascular access. Healthcare providers should identify and quarantine affected lots and follow Bard/BD recall instructions to avoid delays in critical IO access.
Tags: device_recall, intraosseous_access, obturator_locking, bard_access_systems, bd_needle_kit
Class I Recall: Medline TOTAL KNEE-LF Procedure Kit Contains Recalled Bupivacaine Injection
2026-07-29 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 318 TOTAL KNEE-LF medical procedure convenience kits (Recall #Z-2765-2026) because they contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, which was previously recalled due to quality issues that could lead to serious health hazards. The affected kits were distributed nationwide and pose a Class I recall risk. Healthcare providers should immediately quarantine and return any remaining inventory.
Tags: class_i_recall, convenience_kit, bupivacaine_injection, drug_recall, medical_device_kit
Class I Recall: Medline Industries, LP - MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
2026-07-29 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2747-2026 by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n. Quantity: 60 kits.
Medline Industries Recalls C-Section Convenience Kit (SKU DYNJ910835) Containing Bupivacaine Injection
2026-07-29 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is conducting a Class I recall of its C-SECTION convenience kit (SKU DYNJ910835) because it contains a B. Braun component that includes Bupivacaine Hydrochloride in Dextrose Injection with a potential health hazard. The recall affects 56 kits distributed in the US. Users should immediately quarantine the affected kits and return them to Medline.
Tags: class_i_recall, convenience_kit, bupivacaine_injection, medline_industries, surgical_kit
Class I Recall: Medline Industries, LP - MEDLINE HIP CDS-LF Procedure Kit Contains Recalled Bupivacaine Injection
2026-07-29 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 52 units of its MEDLINE ‘HIP CDS-LF’ procedure convenience kit after discovering they contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP that were recalled due to quality issues posing a health hazard. The recall is Class I, the most serious type, because use of the affected product could lead to serious adverse health consequences. Healthcare facilities should immediately quarantine and discontinue use of the affected kits and contact Medline for return or disposal instructions.
Tags: class_i_recall, medline, procedure_kit, bupivacaine, drug_device_combination, pain_management, safety_alert
Class I Recall: Medline Industries, LP - MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYK
2026-07-29 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2749-2026 by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n. Quantity: 2301 kits.
Recall: Spectral Instruments Inc Lago X - Momentary Absence of 'X-Ray On' Banner During Readiness Check
2026-07-24 | FDA | Safety Communication | !!! HIGH
FDA has posted a recall (Z-2939-2026) for the Spectral Instruments Inc Lago X imaging device due to a momentary absence of the on-screen 'X-Ray On' banner during the run readiness check. This could prevent operators from being alerted that X-ray emission is active, potentially leading to unintended radiation exposure. Affected facilities should identify impacted Lago X units and follow the manufacturer's recall instructions, including any software updates or workflow mitigations.
Tags: fda_recall, x_ray_safety, radiation_exposure, medical_device_compliance, software_defect
FDA Recall: Spectral Instruments Inc Ami HTX – Missing On-Screen "X-Ray On" Banner (Z-2940-2026)
2026-07-24 | FDA | Safety Communication | !!! HIGH
FDA has posted recall Z-2940-2026 for the Spectral Instruments Inc Ami HTX imaging system due to a momentary absence of the on-screen "X-Ray On" banner during the run readiness check. This may leave operators unaware that X-ray output is active, creating a potential radiation safety risk. Affected facilities should identify impacted units and follow the manufacturer's recall instructions promptly.
Tags: fda_recall, radiation_safety, xray_imaging
Class I Recall: Abiomed Impella CP Set Due to Visually Undetectable Introducer Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has initiated a Class I recall for 87,277 units of its Impella CP Set (Pump Set Code 0048-0003) after identifying a manufacturing defect in 14Fr and 23Fr introducers that can cause leakage from under the sheath cap and along hub score lines. The defect is not visually detectable and poses serious health risks, including bleeding or air embolism. Healthcare providers should immediately stop using affected devices, quarantine them, and follow Abiomed's return instructions.
Tags: class_i_recall, abiomed, impella_cp_set, introducer_leakage, patient_safety
Class I Recall: Abiomed Impella CP Introducer Kit 14Fr (Code 0052-0038) Due to Sheath Leak Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 1,540 units of the Impella CP Introducer Kit 14 Fr, 13 cm (Pump Set Code 0052-0038) because the introducer sheath can leak from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable and poses serious health risks, including bleeding or air embolism. The firm issued an Urgent Medical Device Recall letter instructing customers to immediately quarantine and return all affected kits.
Tags: class_i_recall, impella_cp_introducer, sheath_leakage, abiomed, medical_device_safety
Class I Recall: Abiomed Impella CP Introducer Kit 14Fr Due to Undetectable Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 846 units of its Impella CP Introducer Kit (14 Fr, 13 and 25 cm, Pump Set Code 1000550) because of a manufacturing issue that can cause introducer sheath leakage under the cap or along hub score lines, which is not visible to the user. If leaks occur, patients may experience bleeding, air embolism, or loss of hemodynamic support, creating a serious health hazard. Healthcare facilities should immediately quarantine and return all affected devices to Abiomed.
Tags: class_i_recall, impella_introducer, sheath_leakage, abio_med, cardiac_device
Oscor Inc. Recalls Abiomed Introducer Kit for Impella Due to Leak Risk (Class I)
2026-07-22 | FDA | recall_class1 | !!! HIGH
Oscor Inc. has initiated a Class I recall of the Abiomed Introducer Kit (REF 0052-3025), a hemostatic peel-away introducer used with Impella catheters, due to manufacturing defects that can cause leakage from the sidearm, under the sheath cap, and along hub score lines. This defect may lead to blood loss, air embolism, or loss of hemostasis, posing serious health risks. The recall covers 355 units distributed in the U.S.; healthcare facilities should immediately stop using affected kits, quarantine all stock, and return them to Oscor Inc.
Tags: class_i_recall, introducer_kit, leak_risk, air_embolism, oscor_inc, impella
Class I Recall: Argon Medical Devices, Inc - General Biospy Tray, REF: GUTS1000
2026-07-22 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2706-2026 by Argon Medical Devices, Inc. Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.. Quantity: 1800.
Class I Recall: Argon Medical Devices Arterial Line Kit Due to Non-Sterile Lidocaine Ampules
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling 440 units of its Arterial Line Kit (REF 400115A) because the kit contains Lidocaine HCL Injection USP 1% ampules that are subject to another recall for failing sterility release criteria. This Class I recall, the most serious type, presents a risk of serious infection or death if the non-sterile solution is used. Customers should immediately quarantine and discontinue use of all affected kits and return them to the firm.
Tags: class_i_recall, sterility_issue, arterial_line_kit
Class I Recall: Abiomed Insertion Kit (JP Set 0052-0011-JP) due to Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its ABIOMED Insertion Kit, packaged for Japan (Pump Set Code 0052-0011-JP), containing 14Fr and 23Fr Introducers. The recall is due to a potential for introducer sheath leakage from under the cap and along hub score lines, a manufacturing defect that is not visually detectable and could lead to air embolism or bleeding. A total of 117 units are affected, and customers must immediately quarantine, discontinue use, and return the product.
Tags: class_i_recall, abiomed, introducer_sheath, leakage_risk, patient_safety
Class I Recall: Argon Medical Transvenous Pacing Electrode Tray (REF:0) for Sterility Failure of Lidocaine Ampules
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling 950 units of its Transvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode 5F (REF:0) because the kits contain Lidocaine HCl Injection USP 1% ampules that failed sterility release criteria. This Class I recall indicates a reasonable probability of serious infection risk or other adverse health consequences. Healthcare facilities should immediately quarantine affected products and follow the firm's recall instructions.
Tags: class_i_recall, sterility_failure, pacing_electrode, argon_medical
Class I Recall: Oscor Inc. – Abiomed Introducer Kit for Impella Hemostatic Peel Away Intro – Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Oscor Inc. has initiated a Class I recall for 1332 units of the Abiomed REF 0052-3021 Introducer Kit for Impella Hemostatic Peel Away Intro. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, or along hub score lines, posing risks of blood loss, air embolism, or infection. Healthcare facilities should immediately stop use, quarantine affected products, and return them to Oscor per recall instructions.
Tags: class_i_recall, introducer_sheath_leakage, manufacturing_defect, oscor, abiomed, cardiovascular_device
Class I Recall: Argon Medical Devices One-Piece Introducer Tray Due to Non-Sterile Lidocaine
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling its One-Piece Introducer Tray (REF 497455, 497434) because the kit contains Lidocaine HCL Injection USP 1% ampules that failed sterility release criteria, prompting a separate recall. This Class I recall affects 200 units distributed in the U.S. and poses a risk of serious infection or sepsis if non-sterile lidocaine is used. Users should immediately quarantine and discontinue use of affected lots, and return products to Argon Medical as directed.
Tags: class_i_recall, sterility_issue, lidocaine, one_piece_introducer_tray, argon_medical, cardiovascular
Class I Recall: Abiomed, Inc. - ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product C
2026-07-22 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2689-2026 by Abiomed, Inc.. Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th. Quantity: 35,430 units.
Class I Recall: Abiomed Impella CP 14 Fr Introducer Kit Recalled Due to Undetectable Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 1,223 units of the Impella CP Introducer Kit 14 Fr (pump set code 0052-0039) because of potential introducer sheath leakage from under the cap and along hub score lines, a manufacturing defect not visually detectable. This Class I recall poses serious health risks including air embolism, bleeding, or infection. Healthcare providers must immediately quarantine the affected devices and follow Abiomed's return instructions.
Tags: class_i_recall, impella_cp, introducer_sheath, manufacturing_defect
Class I Recall: Argon T-Lok Bone Marrow Trays Due to Non-Sterile Lidocaine Ampules
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling 850 T-Lok Bone Marrow Trays (REF BMT1104STL, BMET1104TL, BMT1104CATL) because the kits contain Lidocaine HCL Injection USP 1% 5mL ampules subject to another recall for failing sterility release criteria. Use of a non-sterile ampule poses a risk of serious infection, prompting this Class I recall, the most serious type. Affected facilities should immediately quarantine all impacted lots and follow Argon’s instructions for return or disposal.
Tags: class_i_recall, sterility_failure, bone_marrow_tray, argon_medical, lidocaine, medical_device_recall
Class I Recall: Abiomed Impella 5.5 SmartAssist S2 Set Recalled for Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 1,574 units of the Impella 5.5 SmartAssist S2 Set (pump set codes 1000459, 1000460, JP configuration) due to a manufacturing defect in 14Fr and 23Fr introducers that may cause leakage under the sheath cap or along hub score lines. This Class I recall, the most serious type, warns that the undetectable leak could lead to hemorrhage, air embolism, or inadequate hemodynamic support. The affected devices were distributed in Japan; users must immediately discontinue use, quarantine the product, and contact Abiomed for return and replacement.
Tags: class_i_recall, introducer_sheath_leakage, abiomed_impella, high_risk, medical_device
Class I Recall: Abiomed Impella RP Flex Sets Due to Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its Impella RP Flex with SmartAssist Set (pump set code 1000323) because 14Fr and 23Fr introducer sheaths may leak from under the sheath cap and along hub score lines, a manufacturing defect not visually detectable. This could cause bleeding, air embolism, or other serious patient injury. The Class I recall covers 5,017 units distributed in the U.S. Healthcare providers must immediately stop using and quarantine affected products and return them to Abiomed.
Tags: class_i_recall, abiomed, introducer_sheath_leakage
Class I Recall: Abiomed Impella CP Set with Introducer Product C (Code 0048-0044) Due to Introducer Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is conducting a Class I recall of 557 units of the Impella CP Set (Pump Set Code 0048-0044) containing Introducer Product C. The recall is due to a manufacturing defect in 14Fr and 23Fr introducers that can cause sheath leakage from under the cap or along hub score lines, not visually detectable. This poses a risk of air embolism, bleeding, or inadequate circulatory support. Users must immediately quarantine affected products and return them to Abiomed.
Tags: class_i_recall, cardiac_assist_device, introducer_leakage, manufacturing_defect, patient_safety
Abiomed Recalls Impella 5.5 Smart Assist Set Due to Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its Impella 5.5 Smart Assist Set (pump set codes 1000211 and 1000212) due to potential introducer sheath leakage from under the cap and along hub score lines, a manufacturing defect not visually detectable. This Class I recall, the most serious type, covers 383 units and poses a risk of serious adverse health consequences or death. Customers should immediately quarantine affected products and follow Abiomed's recall instructions.
Tags: class_i_recall, abiomed, impella_5_5, introducer_sheath_leakage, cardiovascular_device, recall_z_2687_2026
Class I Recall: Abiomed Intro Kit (14Fr, JP) Due to Risk of Introducer Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 96 units of its ABIOMED Intro Kit, 14Fr x 13 and 25 cm, packaged for Japan (Pump Set Code 0052-0023-JP). The recall was initiated due to a manufacturing defect that may cause introducer sheath leakage from under the sheath cap and along hub score lines; this defect is not visually detectable and could lead to air embolism or bleeding. Users must immediately stop using the affected products, quarantine them, and return them to the firm. This is a Class I recall, the most serious type, indicating a reasonable probability of serious health consequences or death.
Tags: class_i_recall, introducer_sheath_leakage, abiomed, manufacturing_defect, air_embolism, cardiovascular_device
Class I Recall: Abiomed Impella CP Smart Assist Set (JP, Code 0048-0024-JP) for Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 8,382 units of its Impella CP Smart Assist Set, JP (Pump Set Code 0048-0024-JP) due to potential introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr Introducers. The defect is not visually detectable and could lead to patient complications such as bleeding or vascular injury. Healthcare facilities should immediately quarantine affected products and follow Abiomed’s recall instructions.
Tags: class_i_recall, impella, introducer_sheath, patient_safety
Abiomed Recalls 14Fr Low Profile Catheter Introducer Kits
2026-07-21 | FDA | cdrh_news | !!! HIGH
Abiomed is recalling its 14Fr Low Profile Introducer Kits (used with Impella heart pumps) due to a potential tip separation issue that could lead to vascular injury or procedure delay. The FDA has classified this as a Class I recall, the most serious type, requiring immediate discontinuation of use. Healthcare facilities should quarantine all affected units and follow Abiomed's instructions for return or replacement.
Tags: catheter_introducer_kit, recall, abiomed, impella, class_i, medical_device
B. Braun Medical Removes Spinal Anesthesia Kits Containing Huons Bupivacaine HCl in Dextrose Due to Quality Issue
2026-07-21 | FDA | cdrh_news | !!! HIGH
B. Braun Medical, Inc. is voluntarily removing certain convenience kits that include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to a potential quality defect that may compromise product integrity, leading to risk for patients. Healthcare facilities should immediately stop using and quarantine affected kits, and contact B. Braun to arrange return. This is a safety-related removal coordinated with FDA CDRH.
Tags: recall, spinal_anesthesia, b_braun, convenience_kit, quality_defect, cdrh
Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine, Bupivacaine, and Saline
2026-07-21 | FDA | cdrh_news | !! MEDIUM
Arrow International is issuing a field correction for certain convenience kits that include Huons-manufactured lidocaine, bupivacaine, and saline separately recalled by Huons due to lack of sterility assurance. The correction involves notifying users to quarantine and remove the affected drug components from the kits and arrange for their return. Healthcare facilities that received the impacted kits should immediately check inventory, stop using the specified drug vials, and follow Arrow International's removal instructions.
Tags: convenience_kit, drug_recall, field_correction, arrow_international, huons, lidocaine, bupivacaine, sterility_assurance
FDA CDRH Town Hall on Biocompatibility and Toxicological Risk Assessment – October 7, 2026
2026-07-21 | FDA | cdrh_news | !! MEDIUM
The FDA's Center for Devices and Radiological Health (CDRH) is hosting a virtual Town Hall on biocompatibility and toxicological risk assessment on October 7, 2026. The event provides medical device manufacturers and stakeholders an opportunity to engage with FDA experts on current expectations, challenges, and evolving best practices for demonstrating biocompatibility under ISO 10993. Attendees can submit questions in advance and participate in live discussions to clarify regulatory pathways for chemical characterization and toxicological risk assessment.
Tags: biocompatibility, toxicological_risk_assessment, town_hall, cdrh, iso_10993, medical_devices
FDA CDRH Town Hall on Biocompatibility and Chemical Characterization: Focus on Extractions (Sep 23, 2026)
2026-07-21 | FDA | cdrh_news | !! MEDIUM
The FDA's Center for Devices and Radiological Health (CDRH) will host a virtual town hall on September 23, 2026, dedicated to biocompatibility and chemical characterization testing with a specific focus on extraction protocols. Medical device manufacturers preparing premarket submissions should attend to understand current expectations for extraction study design, solvent selection, and data interpretation. This event provides a direct opportunity to ask questions and clarify regulatory requirements under ISO 10993-18 and related guidance.
Tags: biocompatibility, chemical_characterization, extractions, town_hall, iso_10993, fda_cdrh
FDA CDRH Announces Town Hall on Biocompatibility Risk Assessment on September 9, 2026
2026-07-21 | FDA | cdrh_news | !! MEDIUM
The FDA’s Center for Devices and Radiological Health (CDRH) will hold a town hall on September 9, 2026, focused on biocompatibility risk assessment for medical devices. This event is intended for medical device manufacturers and regulatory affairs professionals seeking clarity on current expectations for biocompatibility evaluation. Participants will have the opportunity to engage directly with FDA experts, ask questions, and discuss best practices. Manufacturers are encouraged to register in advance and prepare specific questions related to their biocompatibility assessment strategies.
Tags: biocompatibility, risk_assessment, town_hall, cdrh, medical_device, regulatory_affairs
FDA Recall Z-2954-2026: SDI Limited - Dentsply Sirona Capsule Mixer Model 5546068 Electrical Discharge Risk
2026-07-20 | FDA | Safety Communication | !!! HIGH
FDA posted recall Z-2954-2026 for the SDI Limited - Dentsply Sirona Capsule Mixer, Model No. 5546068, due to potential electrical discharge from the unit when unplugged. This dental device may pose an electrical shock hazard to users. Affected facilities should identify and remove the device from use and follow the manufacturer's recall instructions.
Tags: device_recall, electrical_safety, dental_device
Paragonix KidneyVault Portable Renal Perfusion System Recall Z-2967-2026: Firmware Defect Causes Blank Screen
2026-07-20 | FDA | Safety Communication | !!! HIGH
FDA has posted a recall for the Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System, REF PRGNX-8008-001, under recall Z-2967-2026. A firmware defect in the datalogger may cause it to lose its configuration, resulting in a blank screen and loss of displayed preservation parameters. This can prevent transplant teams from monitoring critical organ preservation data during transport. Affected facilities should identify and quarantine affected units, contact Paragonix Technologies, and follow the recall instructions.
Tags: device_recall, firmware_defect, organ_preservation, fda_safety_communication
Recall: Thermo Fisher Neisseria meningitidis Gp C Antisera (R30166901) Fails IFU Performance, Not Positive within 60 Seconds
2026-07-17 | FDA | Safety Communication | !!! HIGH
The FDA has issued a Class I recall for specific lots of Remel Europe Ltd. / Thermo Fisher Diagnostics Neisseria meningitidis Gp C antisera (R30166901). The affected product does not yield a positive reaction with the ATCC13102 control strain within 60 seconds as required by the instructions for use, potentially leading to false-negative results. Misidentification of Neisseria meningitidis serogroup C may delay appropriate treatment and infection control measures, posing serious health risks. Laboratories should immediately discontinue use of the impacted lots, quarantine remaining inventory, and contact Thermo Fisher for replacement. All results obtained with these lots should be re-evaluated.
Tags: device_recall, fda_safety_alert, invitro_diagnostics, neisseria_meningitidis, false_negative, class_i_recall
Biofire Defense Recalls FilmArray NGDS Warrior Panel Due to Outbreak Strain Mismatch
2026-07-16 | FDA | Safety Communication | !!! HIGH
Biofire Defense has recalled the FilmArray NGDS Warrior Panel (REF NGDS-ASY-0007, UDI-DI (01)00851458005136) because the reference strains used in test development do not match circulating outbreak strains, which may cause false negative or inaccurate results. Affected product should be immediately removed from use, quarantined, and returned or disposed of as directed by the firm. The FDA has classified this as a Class II recall (Z-2877-2026).
Tags: device_recall, class_ii_recall, ivd_panel, nucleic_acid_test, biofire_defense, filmArray, safety_alert
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Catheter Delivery Catheter System (DCS)
2026-07-14 | FDA | cdrh_news | !! MEDIUM
CDRH News
CDRH News: FDA Small Business Determination (SBD) Program Offers Reduced or Waived Medical Device User Fees
2026-07-14 | FDA | cdrh_news | !! MEDIUM
This CDRH news item provides an overview of the FDA’s Small Business Determination (SBD) program, which allows qualifying small businesses to receive reduced or waived user fees for certain medical device premarket submissions. Eligible firms must meet gross receipts thresholds and submit an SBD request using Form 3602 or 3602A. The update clarifies eligibility criteria, application steps, and the need for an active SBD number before submitting a fee‑based application. Manufacturers are advised to apply early to avoid processing delays.
Tags: small_business, user_fee, sbd_program, cdrh_news, medical_device
Class I Recall: Insulet Corporation - Omnipod 5 Pods (POD-OMNI-I1-6720) Due to Cannula Damage and Insulin Leakage
2026-07-08 | FDA | recall_class1 | !!! HIGH
Insulet Corporation is recalling 4,936,056 Omnipod 5 Pods (model POD-OMNI-I1-6720) because a manufacturing defect in the external soft cannula may cause insulin to leak around the Pod, leading to under-delivery. This Class I recall—the most serious type—poses risks of hyperglycemia and diabetic ketoacidosis. Users should immediately check their device and contact Insulet for a replacement or further guidance.
Tags: class_i_recall, insulin_pump, omnipod, cannula_damage, insulin_leakage, patient_safety
Class I Recall: Baxter's Hillrom VOLARA System Patient Circuit Kits Recalled Due to Air and Medication Leakage from Nebulizer Cup
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation has initiated a Class I recall for 16,187 units of its Hillrom VOLARA System P.CIRCUIT KIT AC (single patient use circuit) due to reports of air and medication leakage from the nebulizer cup. This leakage can cause a drop in the patient's oxygen level and ineffective therapy, posing a serious health hazard. The FDA classifies this as the most serious type of recall; healthcare providers should immediately stop using affected circuits, quarantine them, and return the products to Baxter.
Tags: class_i_recall, nebulizer_leakage, respiratory_device
Class I Recall: Hamilton Medical AG Coaxial Breathing Circuit Set – Sticking Valve Membranes Risk Obstructed Exhalation
2026-07-08 | FDA | recall_class1 | !!! HIGH
Hamilton Medical AG has initiated a Class I recall for its coaxial breathing circuit sets (REF 260127, 260128, 260167, 260168) used with Hamilton Medical ventilators. The expiratory valve membranes may stick to the valve body, an issue not detectable during pre-operative testing, causing an 'exhalation obstructed' alarm and potentially leading to ventilation failure and serious patient harm. The recall covers 27,270 units distributed in the U.S. Users should immediately quarantine the affected products, identify them by reference number, and contact the manufacturer for replacement or further instructions per the recall notice.
Tags: class_i_recall, ventilator, breathing_circuit, exhalation_valve
Class I Recall: Insulet Corporation - Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5
2026-07-08 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2604-2026 by Insulet Corporation. Reason: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode . Quantity: 1,790,784 units.
Class I Recall: Windstone Medical Packaging Recalls AMS7200D Surgical Kits Due to Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. is conducting a Class I recall of its AMS, Aligned Medical Solutions, Dr. Lewin Pack (Pack Number AMS7200D) surgical kits because they contain Webcol Large Alcohol Prep Pads recalled by Cardinal Health. The prep pads were found to be contaminated with Paenibacillus phoenicis, posing a risk of serious infection. Only 45 units are affected. Customers should immediately quarantine and return any affected kits to the recalling firm.
Tags: class_i_recall, windstone_medical_packaging, alcohol_prep_pad, microbial_contamination, surgical_kit
Class I Recall: Windstone Medical Packaging’s AMS Thyroid FNA Pack-RX Contains Recalled Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. is recalling 200 units of Aligned Medical Solutions Thyroid FNA Pack-RX (pack number AMS17729) because the kits include Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after a contaminant, Paenibacillus phoenicis, was found during a routine sterilization dose audit. This Class I recall is the most serious type, as use of the contaminated prep pads could lead to life-threatening infections, particularly in immunocompromised patients. The products were distributed to medical facilities performing thyroid fine-needle aspiration procedures. Customers must immediately stop using the kits, quarantine all affected units, and return them to Windstone Medical Packaging.
Tags: class_i_recall, contaminated_device, alcohol_prep_pad, thyroid_fna_kit, windstone_medical, paenibacillus_phoenicis
Class I Recall: Baxter's Hillrom VOLARA System Circuit Kits – Nebulizer Cup Leakage Can Drop Patient Oxygen Levels
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation has issued a Class I recall for 13,881 units of its Hillrom VOLARA System P.CIRCUIT 5KIT AC single-patient use circuits. Air and medication leakage from the nebulizer cup during therapy may cause a drop in the patient's oxygen level and reduce treatment effectiveness. This recall, the most serious type, requires healthcare providers to immediately cease using affected circuits, quarantine them, and follow Baxter's return or disposal instructions. No injuries have been reported yet, but the hazard is significant.
Tags: class_i_recall, fda, baxter, volara, respiratory_device, safety_alert
Medtronic Recalls Harmony Delivery Catheter System Due to Distal Tip Detachment Risk (Class I Recall)
2026-07-08 | FDA | recall_class1 | !!! HIGH
The FDA has classified Medtronic Heart Valves Division's recall of its Harmony Delivery Catheter System as Class I due to a potential for distal tip detachment from specific manufacturing lots. This issue may lead to embolization, vascular injury, or the need for emergency surgical intervention. A total of 1,881 units are affected. Healthcare providers should immediately stop using the affected lots, quarantine the products, and follow Medtronic's instructions for return and patient management.
Tags: class_i_recall, medtronic, harmony_delivery_catheter, tip_detachment, fda_recall
Medline Industries Recalls Reprocessed Electrophysiology and Ultrasound Catheters Due to Particulate Contamination (Z-2615-2026)
2026-07-08 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is conducting a Class I recall of specific lots of reprocessed electrophysiology and ultrasound catheters (Recall #Z-2615-2026). The devices may contain small residual particles on patient-contacting surfaces, posing a risk of embolization or other serious harm if used. This recall expands RES 98277 and affects 3 units. Healthcare facilities should immediately quarantine affected products and follow the firm’s return or disposal instructions.
Tags: class_i_recall, particulate_contamination, reprocessed_catheters, patient_safety_hazard
Class I Recall: Windstone Medical DSAEK Pack-RX Kits with Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. is recalling 1,080 DSAEK Pack-RX surgical kits (Pack Number AMS12394B) because they include Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after routine sterilization audits detected Paenibacillus phoenicis contamination. Use of the affected kits could lead to serious infections in surgical patients. Healthcare providers should immediately quarantine all kits, stop usage, and return them to the recalling firm.
Tags: class_i_recall, surgical_kit, alcohol_prep_pad
Class I Recall: Windstone Medical Packaging Preop Kit-NS (AMS18227) Due to Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. has issued a Class I recall for ALIGNED MEDICAL SOLUTIONS Preop Kit-NS, pack number AMS18227, following the contamination of included Webcol Large Alcohol Prep Pads with Paenibacillus phoenicis. The pads were previously recalled by Cardinal Health after the contaminant was discovered during a routine sterilization dose audit, posing a risk of serious infection. The recall covers 200 units distributed in the U.S. Users should immediately quarantine and discontinue use of the affected kits, and return them to the recalling firm.
Tags: class_i_recall, contamination, surgical_prep_kit, alcohol_prep_pad, paenibacillus_phoenicis, windstone_medical_packaging, aligned_medical_solutions, recall_z-2621-2026
Class I Recall: Insulet Corporation - Omnipod (Eros) Pod due to Cannula Damage and Insulin Leakage
2026-07-08 | FDA | recall_class1 | !!! HIGH
Insulet Corporation is recalling 289,046 units of its Omnipod (Eros) Pod (model POD-ZXP425) due to external soft cannula damage during manufacturing, which can cause insulin to leak around the Pod instead of being delivered, potentially leading to under-delivery and hyperglycemia. The FDA has classified this as a Class I recall, the most serious type, indicating a reasonable probability of serious adverse health consequences or death. Users should immediately inspect their Pods, discontinue use of affected lots, and contact Insulet for replacements while monitoring blood glucose closely.
Tags: class_i_recall, omnipod, insulin_pump, cannula_damage
Class I Recall: Baxter Healthcare Hillrom VOLARA System P.CIRCUIT KIT – Nebulizer Cup Leakage Causing Oxygen Drop
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation has initiated a Class I recall of 10,540 units of the Hillrom VOLARA System P.CIRCUIT KIT due to air and medication leakage from the nebulizer cup during therapy. This fault can cause a drop in the patient's oxygen level and render treatment ineffective, posing serious health risks. All affected circuits should be immediately quarantined and returned to Baxter for replacement.
Tags: class_i_recall, respiratory_device, nebulizer_leakage, patient_safety, fda
Baxter Recalls Hillrom Volara P.Circuit 5KIT Due to Nebulizer Cup Leakage Causing Oxygen Drop
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation is conducting a Class I recall of the Hillrom Volara P.Circuit 5KIT (single patient use circuit) because of air and medication leakage from the nebulizer cup during therapy. This defect can lead to a dangerous drop in the patient’s oxygen level and render the treatment ineffective. The recall impacts zero units (likely a field correction notification), and users must immediately discontinue use of affected circuits and follow the manufacturer’s instructions.
Tags: class_i_recall, baxter_healthcare, hillrom_volara, circuit_leakage, oxygen_desaturation, nebulizer_defect
Olympus OEV321UH 4K UHD Monitor Recall: Faulty HDMI/DisplayPort Connectors May Cause Image Loss
2026-07-07 | FDA | Safety Communication | !!! HIGH
Olympus Corporation of the Americas is recalling its OEV321UH 4K UHD LCD Monitor (Recall Z-2761-2026) because the HDMI and DisplayPort connectors can become faulty, leading to image loss or image abnormalities during use. This defect poses risks of misdiagnosis or surgical complications if the monitor is relied upon for visualization. The FDA has issued this as a serious safety communication. Healthcare providers should immediately identify and cease use of affected units, and contact Olympus for remediation instructions.
Tags: recall, olympus, hdmi_dp_fault
Device Recall: INTEGRATED MEDCRAFT LLC - FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-4
2026-07-07 | FDA | Safety Communication | !! MEDIUM
Recall Z-2836-2026: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Recall: Integrated Medcraft Kingfisher First Aid Kit (REF 76656) – Guedel Airway Occlusion Hazard
2026-07-07 | FDA | Safety Communication | !!! HIGH
Integrated Medcraft LLC is recalling its Kingfisher Compact Individual First Aid Kit (REF 76656) because the included one-piece Guedel airway may have a fully or partially occluded tip. This defect could obstruct airflow, delaying emergency ventilation and potentially causing serious injury or death. Distributors and end-users should immediately quarantine affected kits and contact the firm for return or replacement.
Tags: recall, fda_safety_communication, airway_obstruction, first_aid_kit, guedel_airway, integrated_medcraft
FDA Class I Recall: Insulet Removes Omnipod Pods Insulin Pump Due to Under-Delivery Risk
2026-07-03 | FDA | cdrh_news | !!! HIGH
The FDA has announced a Class I recall for Insulet's Omnipod Pods, used with the Omnipod DASH Insulin Management System, due to a missing cannula or needle that can result in under-delivery of insulin. This poses risks of hyperglycemia, diabetic ketoacidosis, and death. Patients and caregivers must immediately stop using affected lots, contact Insulet for replacements, and transition to an alternative insulin delivery method.
Tags: insulin_pump, class_I_recall, omnipod, diabetes_device, safety_alert, insulet
Abiomed Recalls Impella CP Sets with SmartAssist Due to Potential for Catheter Perforation
2026-07-03 | FDA | cdrh_news | !!! HIGH
Abiomed is recalling its Impella CP with SmartAssist sets after reports of the catheter tip breaking or perforating during insertion, which could lead to serious injury or death. The FDA has classified this as a Class I recall, the most serious type. Health care providers should immediately stop using affected devices and follow Abiomed's instructions for return and replacement. The recall affects certain lots distributed from August 2021 to March 2023.
Tags: recall, class_i, impella_cp, smartassist, heart_pump, abiomed, catheter_perforation
Class I Recall: Abiomed, Inc. - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 168 units of its Impella CP Set with SmartAssist (10th Generation) that contain the affected component 14. The recall was initiated due to the potential for thrombus formation during prolonged use of the introducer. Customers should immediately locate and quarantine the affected sets, discontinue use, and return them to Abiomed as instructed in the firm's Urgent Medical Device Recall notice.
Tags: class_i_recall, abiomed, impella_cp, thrombus, introducer
Abiomed Recalls Impella CP Low Profile Introducer Kit Due to Thrombus Risk – FDA Class I Recall
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has initiated a Class I recall of its Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP, part of the Impella Set Pro, due to the potential for thrombus formation during prolonged use. The FDA has classified this as the most serious type of recall, indicating a risk of serious injury or death. A total of 17 units are affected. Healthcare providers should immediately stop using the recalled devices, quarantine them, and contact Abiomed for return instructions.
Tags: fda_class_i_recall, abiomed, impella_cp, introducer_kit, thrombus_risk, medical_device
Class I Recall: Abiomed 14 Fr Low Profile Introducer Kit for Impella CP – Thrombus Formation Risk
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its 14 Fr x 13 cm Low Profile Introducer Kit (used with Impella CP/Impella Set Pro) due to a potential for thrombus formation during prolonged use. This Class I recall, the most serious type, involves only 3 units. Users should immediately quarantine the affected kits and follow the manufacturer’s instructions to prevent possible embolic events.
Tags: class_i_recall, thrombus_formation, impella_cp, abiomed, introducer_kit
Class I Recall: Medline Industries, LP - Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM
2026-07-01 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2452-2026 by Medline Industries, LP. Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality. Quantity: 227 units.
Class I Recall: Medline Industries, LP - Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC0
2026-07-01 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2455-2026 by Medline Industries, LP. Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality. Quantity: 503 units.
Class I Recall: Medline Convenience Kit 'DRAWER 6 CENTRAL LINE INSERTIO' (ACC) with Recalled Lidocaine and Bupivacaine Injections
2026-07-01 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 233 units of its Convenience Kits (DRAWER 6 CENTRAL LINE INSERTIO, Model ACC) because they contain Arrow Kits with recalled Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP. The recalled anesthetic injections pose potential serious health risks due to quality defects, including infection, non-sterility, or adverse patient outcomes. This is a Class I recall, the most serious type. Healthcare providers must immediately stop using affected kits, quarantine them, and contact Medline for return or disposal instructions.
Tags: class_i_recall, medline, convenience_kits, lidocaine_recall, bupivacaine_recall, arrow_kits, drug_quality_defect
Class I Recall: Abiomed Impella CP Set with SmartAssist (10th Gen) Over Introducer Thrombus Risk
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has issued a Class I recall for 7 units of the Impella CP Set with SmartAssist (10th Generation) due to a potential for thrombus formation during prolonged use of the introducer. This defect could lead to serious patient injury or death. Users should immediately quarantine and discontinue use of affected devices and follow the firm's recall instructions. Distribution was limited to a small number of facilities.
Tags: class_i_recall, impella_cp, thrombus_risk
FDA Title 21 CFR Update: Medical Device Parts 800-898 Revised (June 26, 2026)
2026-06-30 | FDA | Regulation Update | !! MEDIUM
The FDA has updated Title 21 of the Code of Federal Regulations (CFR), with the latest revision dated June 26, 2026. This update potentially affects medical device regulations under Parts 800-898. Regulatory affairs professionals should review the amended sections to ensure ongoing compliance for medical device manufacturing, labeling, and quality systems.
Tags: fda, cfr_title_21, medical_device_regulations
Boston Scientific Recalls Rapid Refill Continuous Injection System Due to Risk of Syringe Disconnection from Manifold
2026-06-30 | FDA | Safety Communication | !!! HIGH
The FDA announced a recall of Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) because it contains a recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. The syringe may loosen or completely disconnect from the manifold, potentially causing therapy interruption, blood loss, or air embolism. Healthcare providers should immediately quarantine affected devices and follow Boston Scientific's recall instructions.
Tags: device_recall, fda_safety_alert, syringe_disconnection, boston_scientific, class_i_recall
Kent Imaging Recalls SnapshotGLO Wound Imaging Device Due to Battery Charging Failure
2026-06-30 | FDA | Safety Communication | !!! HIGH
Kent Imaging, Inc. is recalling its SnapshotGLO Wound Imaging Device (Models KB100, KB100AA) because the software controlling the battery charging circuit fails to recover a battery that has fully discharged into a low-power ‘shipping mode’. This prevents the device from recharging, leaving it inoperable when needed for wound assessment. Users should stop using the device if it does not charge and contact the manufacturer for a correction.
Tags: recall, battery_charging, wound_imaging, fda_safety_alert, medical_device
Accuray CyberKnife Xchange Collimator Changer Recalled: Collimator Docking Failure May Cause Injury
2026-06-16 | FDA | Safety Communication | !!! HIGH
Accuray Incorporated is recalling its CyberKnife Treatment Delivery System with Xchange Robotic Collimator Changer due to a risk that a collimator may not fully dock. If personnel enter the treatment room and use the in-room control pendant after a docking interlock, the collimator could fall, posing a serious injury hazard. Users must follow the manufacturer's corrective actions, including not attempting manual motion when the interlock is active.
Tags: recall, radiation_therapy, collimator, safety, linear_accelerator, medical_device
Accuray CyberKnife with Xchange Collimator Changer Recalled for Collimator Docking Failure Hazard
2026-06-16 | FDA | Safety Communication | !!! HIGH
The FDA announced a recall of Accuray's CyberKnife Treatment Delivery System equipped with the Xchange Robotic Collimator Changer. If a collimator does not fully dock, a system interlock may be triggered; should personnel then manually move the robot using the in-room pendant, the collimator could fall, risking injury to patients or staff. Users should immediately inform all operators of this risk and adhere to the manufacturer's interim safety instructions until a permanent correction is deployed.
Tags: device_recall, radiation_oncology, collimator_failure, patient_safety, fda_recall
Recall: Zimmer Surgical Sterile Tourniquet Hoses (A.T.S 4000 TS) – Potential Sterility Breach (Recall Z-2673-2026)
2026-06-09 | FDA | Safety Communication | !!! HIGH
Zimmer Surgical has initiated a recall (Z-2673-2026) of its A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. Use of affected devices could lead to moderate localized infection requiring treatment; if the issue is noticed before use, it may cause a clinically insignificant delay while an alternative device is obtained. Healthcare providers should immediately identify and quarantine all affected units, stop using them, and return them to the manufacturer as instructed.
Tags: device_recall, sterility_breach, tourniquet_hoses, zimmer_surgical
Zimmer Surgical Recalls A.T.S 4000 TS Tourniquet Single Hose Over Potential Sterility Breach
2026-06-09 | FDA | Safety Communication | !!! HIGH
The FDA has announced a recall of Zimmer Surgical's A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors (Recall Z-2674-2026) due to a potential sterility breach in the sealing area of the sterile pouch. If the affected device is used, it may lead to moderate localized infection; if discovered prior to use, it may cause a clinically insignificant extension of surgery while an alternative is sourced. Healthcare providers should immediately identify and quarantine all affected units.
Tags: recall, sterility_breach, tourniquet_hose, zimmer_surgical, infection_risk
FDA Recalls Siemens ARTIS icono ceiling Due to Risk of Monitor Detachment from Ceiling Suspension
2026-06-08 | FDA | Safety Communication | !!! HIGH
The FDA has issued a Class I recall (Z-2648-2026) for the Siemens ARTIS icono ceiling angiography system (model 11328100) due to a potential issue with the Display Ceiling Suspension (DCS Fix XL). Over time, screws securing the monitor to the suspension may gradually loosen, causing the monitor to detach and fall, posing a risk of impact injury to patients or healthcare staff. Affected facilities should immediately inspect the suspension assembly and contact Siemens to arrange for corrective maintenance.
Tags: fda_recall, siemens_medical_solutions, artis_icono_ceiling, ceiling_suspension, loose_screws, safety_alert
Medela Recalls ENFit ExSet Syringes Due to Incompatible Connectors Risking Enteral Feeding Delays
2026-06-05 | FDA | Safety Communication | !!! HIGH
Medela Inc. is recalling its ENFit ExSet Strl 60 2.0ml PV 1ct EN syringe (Model ENF060182LD / 101033086) because the product may contain incorrect connectors that cannot attach or misconnect to ENFit connections. This incompatibility could cause a slight delay in the delivery of enteral nutritional fluids or oral medication. Healthcare providers and patients should immediately identify affected units, discontinue use, and follow the firm's instructions for return or disposal.
Tags: recall, enteral_feeding, connector_safety, fda, medela
Device Recall: Remel, Inc - GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
2026-06-03 | FDA | Safety Communication | !! MEDIUM
Recall Z-2623-2026: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
FDA Revised Cybersecurity Guidance for Medical Devices (Feb 2026)
2026-02-03 | FDA | New Guidance | !!! HIGH
Issued 3 February 2026, superseding the June 2025 version. Aligns with the new QMSR and ISO 13485. Applies to all devices with cybersecurity considerations, not just network-connected devices. Key expectations: Secure Product Development Framework (SPDF), threat modeling, Software Bill of Materials (SBOM), eight security control categories (authentication, authorization, cryptography, integrity, confidentiality, event detection, resiliency, updatability), and coordinated vulnerability disclosure processes.
Tags: cybersecurity, premarket_submission, software, sbom
QMSR Takes Effect -- 21 CFR Part 820 Incorporates ISO 13485:2016
2026-02-02 | FDA | Regulation Update | !!! HIGH
Effective 2 February 2026, the FDA's Quality Management System Regulation (QMSR) amends 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. The legacy Quality System Inspection Technique (QSIT) was discontinued and replaced by Compliance Program 7382.850, aligned with ISO 13485. Manufacturers must now explicitly comply with ISO 13485:2016 requirements. Two older guidance documents (1997 design control guidance and 2008 PMA manufacturing inspection guidance) were withdrawn.
Tags: quality_management, iso_13485, cgmp, inspection