Japan PMDA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Class II Recall: Daiichi Ika's Stella FU-STE ENT Treatment Unit (Recall #2-12921)
2026-08-05 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12921) for the Stella FU-STE ear, nose, and throat (ENT) treatment unit manufactured by Daiichi Ika Co., Ltd. The recall addresses a potential safety issue that may affect device performance and patient safety. Healthcare facilities should immediately stop using the affected device, quarantine it, and contact Daiichi Ika for necessary corrective actions such as repair or replacement.
Tags: japan_pmda, class_ii_recall, ent_device, medical_device_recall, daiichi_ika, stella_fu_ste
[Class II] イオム レガロ (歯科用ユニット) - 株式会社ジーシー
2026-08-04 | Japan PMDA | Safety Communication | !! MEDIUM
Recall #2-12920: 歯科用ユニット / イオム レガロ by 株式会社ジーシー. Type: 医療機器.
Class II Recall: Olympus Disposable Ligation Device (Endoscopic Loop Ligator) – PMDA Recall #2-12918
2026-08-04 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12918) for the Olympus Medical Systems Disposable Ligation Device (Endoscopic Loop Ligator). The recall addresses a potential quality or performance issue that may affect device safety. Healthcare facilities should immediately quarantine affected lots, cease use, and follow Olympus’s return or disposal instructions as detailed in the official recall notice.
Tags: pmda, class_ii_recall, olympus, endoscopic_ligation, disposable_device, medical_device_safety
PMDA Class II Recall: Japan Stryker Sterile Trauma Drill Bits (Surgical Drill Bits)
2026-08-03 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12916) for the Sterile Drill Bits for Trauma (surgical drill bits) distributed by Japan Stryker K.K. The recall addresses a potential safety issue that may cause temporary or medically reversible adverse health consequences. Affected healthcare providers should immediately stop using the product, quarantine remaining inventory, and follow the manufacturer’s instructions for return or disposal.
Tags: pmda, recall, class_ii, orthopedic, surgical_drill, stryker
PMDA Publishes Report on ASEAN-Japan Medical Devices Regulatory Symposium 2026
2026-07-29 | Japan PMDA | Regulation Update | ! LOW
The PMDA has released the report of the ASEAN-Japan Medical Devices Regulatory Symposium 2026, covering discussions on regulatory harmonization, quality management systems, and post-market surveillance between Japan and ASEAN states. The report offers insights for manufacturers and regulatory professionals active in both regions, though it does not introduce new requirements. It may guide future regulatory alignment and cooperation.
Tags: asean, japan, regulatory_symposium, report, medical_devices
ASEAN-Japan Medical Devices Regulatory Seminar 2026 Announced
2026-07-29 | Japan PMDA | Regulation Update | ! LOW
PMDA has announced the ASEAN-Japan Medical Devices Regulatory Seminar scheduled for 2026. This event will cover regulatory harmonization and updates between Japan and ASEAN countries. Medical device manufacturers seeking market access in these regions should note this upcoming opportunity for regulatory insights. No specific date or registration details are provided yet.
Tags: asean, japan, regulatory_seminar, medical_devices, pmda
PMDA Class II Recall: Denver Splint (External Nasal Splint) by Meiyu Co., Ltd.
2026-07-28 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12911) for the Denver Splint, an external nasal splint manufactured by Meiyu Co., Ltd. The recall addresses a potential quality or safety defect that may affect device performance. Healthcare providers and distributors should immediately quarantine impacted units and follow the manufacturer's return or disposal procedures.
Tags: class_ii_recall, nasal_splint, denver_splint, pmda, meiyu
[Class II Recall] Level 1 Hotline Warming Tube (Blood/Fluid Warming Coil) - ICU Medical Japan K.K.
2026-07-28 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA announced a Class II recall (Recall #2-12910) for the Level 1 Hotline Warming Tube, a blood and fluid warming coil manufactured by ICU Medical Japan K.K. The recall is due to a potential quality defect that may affect device safety. Affected healthcare facilities should immediately identify, quarantine, and return the affected units in accordance with the manufacturer's recall instructions.
Tags: class_ii_recall, blood_fluid_warmer, icu_medical_japan, pmda, safety_recall
PMDA Class II Recall: PTA Balloon Catheter II by Firmec Co., Ltd. (Recall No. 2-12909)
2026-07-28 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall for the PTA Balloon Catheter II, a balloon dilatation catheter for percutaneous transluminal angioplasty, manufactured by Firmec Co., Ltd. The recall (No. 2-12909) is due to a potential issue that may affect device performance, such as balloon deflation or rupture. Healthcare facilities are advised to identify and quarantine affected lots, and follow the manufacturer's recall instructions.
Tags: pmda, class_ii_recall, pta_balloon_catheter, firmec, medical_device, japan
Class II Recall: Philips Japan Fetal Monitor FM (分娩監視装置 FM) – Potential Malfunction in Fetal Heart Rate Tracing
2026-07-27 | Japan PMDA | Safety Communication | !! MEDIUM
Philips Japan is conducting a Class II recall of its Fetal Monitor FM (分娩監視装置 FM) due to a potential malfunction that may affect the accuracy of fetal heart rate tracing. This issue could lead to misinterpretation of fetal well-being and delayed clinical intervention. Affected healthcare facilities should immediately follow the manufacturer’s recall instructions, which include device inspection and correction by Philips service personnel.
Tags: class_ii_recall, fetal_monitor, philips_japan, pmda, medical_device_safety
Class II Recall: Meira Compression Hip Screw (Internal Fixation Plate) by Meira Corporation
2026-07-23 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12907) for the Meira Compression Hip Screw, an internal fixation device manufactured by Meira Corporation. The specific safety issue prompting this recall has not been publicly detailed, but the classification indicates a moderate risk where the product may cause temporary or medically reversible health consequences. Healthcare facilities should immediately identify affected inventory, quarantine the devices, and follow the manufacturer’s recall instructions for return or disposal.
Tags: pmda, recall, class_ii, orthopedic_device, hip_screw, meira
Class II Recall: Gunze Medical Cranio Fixation System SHINOBI (Internal Fixation Plate)
2026-07-23 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12906) for the Cranio Fixation System SHINOBI, an internal fixation plate manufactured by Gunze Medical Co., Ltd. This moderate-risk recall addresses a safety issue that could affect device performance. Healthcare facilities should quarantine affected products, stop using them immediately, and follow the manufacturer’s return or disposal instructions.
Tags: japan_pmda, class_ii_recall, cranio_fixation_plate, gunze_medical, shinobi
Class II Recall: Shimadzu LIGHTVISION and LIGHTVISION2 Near-Infrared Camera Systems (Portable Surgical Microscope & ICG Fluorescence Device)
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
Shimadzu Corporation has initiated a Class II recall (No. 2-12903) in Japan for its LIGHTVISION and LIGHTVISION2 near-infrared camera systems, which include portable surgical microscopes and ICG fluorescence observation devices. The recall is due to a potential quality or safety issue that may lead to temporary or reversible health consequences. Affected users should immediately identify and quarantine the devices, and follow the manufacturer's instructions for correction or return.
Tags: japan_pmda, class_ii_recall, near_infrared_camera, shimadzu, lightvision, surgical_microscope, icg_fluorescence
PMDA Class II Recall of Nisshin 救急バンPS Adhesive Bandage (Recall #2-12902)
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II (moderate risk) recall for 救急バンPS adhesive bandage by Nisshin Medical Instrument Co., Ltd. (recall #2-12902). The recall addresses a quality issue that may compromise product safety. Users should stop using affected lots immediately and return or dispose per manufacturer instructions.
Tags: pmda, class_ii_recall, adhesive_bandage, japan, medical_device, nisshin_medical
Class II Recall: GE Healthcare Japan Carestation 600/750 Series Anesthesia Systems
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12901) for GE Healthcare Japan's Carestation 600 and 750 series anesthesia systems. This moderate-level recall is due to a safety-related issue with the device. Affected users should immediately follow the manufacturer's recall notification and implement any recommended corrective actions.
Tags: recall, class_ii, anesthesia_system, ge_healthcare, pmda
PMDA Class II Recall of Intuitive Surgical’s NIR Camera System (Endoscopic Video Camera)
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
Intuitive Surgical’s NIR Camera System (endoscopic video camera) is the subject of a Class II recall in Japan (Recall No. 2-12900), indicating a moderate risk. The specific safety issue or reason for the recall was not detailed in the initial notice. Healthcare facilities using this device should consult the PMDA recall database and follow any manufacturer instructions to address the recall.
Tags: pmda_recall, class_ii, intuitive_surgical, endoscopic_camera, nir_camera, medical_device, japan
PMDA Class II Recall: Mesh Carrier (Skin Graft Expander) by Keisei Medical Industry
2026-07-17 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12899) for the Mesh Carrier (autologous skin graft expander) manufactured by Keisei Medical Industry Co., Ltd. This recall addresses a safety issue with the device used in skin grafting procedures. Healthcare facilities should immediately check their inventory, quarantine affected products, and follow the manufacturer's instructions for return or disposal.
Tags: japan_pmda, class_ii_recall, skin_graft_expander, mesh_carrier, medical_device
Class II Recall for Nipro NAZ-1 Blood Purification Device in Japan (Recall No. 2-12897)
2026-07-15 | Japan PMDA | Safety Communication | !! MEDIUM
Japan's PMDA has issued a Class II (moderate risk) recall for the NAZ-1 multi-purpose blood processing device by Nipro Corporation. The alert references recall number 2-12897, though the specific safety issue and corrective actions were not detailed in the initial notification. Healthcare facilities and users of this device should review the official PMDA recall notice for full instructions.
Tags: japan, class_ii_recall, blood_purification_device, nipro, pmda
PMDA Class II Recall: Nipro SafeTech Pro Syringe Pump Unit
2026-07-15 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II recall (No. 2-12896) for the SafeTech Pro Syringe Pump Unit, a syringe-type infusion pump manufactured by Nipro Corporation. The recall addresses a potential performance issue that could affect infusion accuracy or device reliability. Affected healthcare facilities should immediately review the recall notice, identify devices with the specified serial numbers, and follow Nipro's instructions for corrective action such as inspection, repair, or replacement.
Tags: pmda_recall, class_ii, syringe_pump, infusion_pump, nipro, medical_device, safety_correction
Class II Recall: Boston Scientific Japan OverStitch Single-Use Automatic Suturing Device
2026-07-14 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12894) for the OverStitch single-use automatic suturing device, manufactured by Boston Scientific Japan. The recall addresses a potential safety or performance issue that could compromise device function during use. Affected healthcare facilities should immediately quarantine unused devices, discontinue use, and contact the manufacturer for return or proper disposal. This moderate-risk recall requires prompt action to prevent patient harm.
Tags: class_ii_recall, surgical_suture_device, boston_scientific, pmda, medical_device_safety
Class II Recall: Clean Air ASTRAL Adult Ventilator by ResMed Ltd. (Japan PMDA Recall No. 2-12893)
2026-07-14 | Japan PMDA | Safety Communication | !! MEDIUM
The Japan PMDA has issued a Class II recall (No. 2-12893) for the Clean Air ASTRAL adult ventilator manufactured by ResMed Ltd. This recall is due to a potential safety concern that could affect device performance, posing a moderate risk to patients. Healthcare facilities should immediately identify affected units, discontinue use if necessary, and contact the manufacturer for inspection, repair, or replacement as appropriate.
Tags: japan_pmda, class_ii_recall, ventilator, resmed, safety
Japan PMDA Class II Recall: Dilasoft Cervical Dilator by TKB Co., Ltd.
2026-07-13 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall for the Dilasoft cervical dilator (子宮頚管拡張器) manufactured by TKB Co., Ltd. (株式会社ＴＫＢ). This recall addresses a potential quality issue that could affect device safety or performance. Healthcare providers should immediately quarantine and return affected units to the manufacturer.
Tags: japan_pmda, class_ii_recall, cervical_dilator, medical_device
Class II Recall: Atom Medical FSV Central Monitor (Recall #2-12887)
2026-07-13 | Japan PMDA | Safety Communication | !! MEDIUM
Atom Medical Corporation has issued a Class II recall (No. 2-12887) for its FSV Central Monitor due to a potential safety issue that could affect device performance. Affected devices should be immediately taken out of service, and healthcare facilities should follow the manufacturer's instructions for return or corrective action. The recall notice is posted on the PMDA website for further details.
Tags: recall, class_ii, central_monitor, atom_medical, patient_monitoring, japan_pmda, medical_device_safety
Class II Recall: Cerabian ZR Dental Porcelain by Kuraray Noritake Dental Inc.
2026-07-10 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12886) for Cerabian ZR, a dental porcelain product manufactured by Kuraray Noritake Dental Inc. The recall addresses a specific quality or safety concern; healthcare professionals should consult the official notice for details. Affected users must immediately stop using the involved lots and contact the manufacturer for appropriate corrective actions.
Tags: dental_porcelain, class_ii_recall, japan_pmda, medical_device, cerabian_zr
Class II Recall: Fukuda Denshi Servo Ventilator System (General-Purpose Ventilator)
2026-07-09 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12885) for the Servo Ventilator System, a general-purpose ventilator manufactured by Fukuda Denshi Co., Ltd., due to a potential safety issue. Healthcare facilities using this device should immediately review the recall notice and follow the manufacturer’s instructions for corrective action.
Tags: pmda_recall, class_ii, ventilator, fukuda_denshi, medical_device_safety
Class II Recall of Noritsu Precision Enteral Feeding Pump CP-55E (Enteral Nutrition Infusion Pump) in Japan
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall for the Enteral Feeding Pump CP-55E, an enteral nutrition infusion pump manufactured by Noritsu Precision Co., Ltd. This recall addresses a safety-related issue that may affect device performance or labeling. Healthcare facilities using this pump should immediately identify affected units, cease use if instructed, and follow the manufacturer’s corrective actions as detailed in the recall notice.
Tags: class_ii_recall, enteral_feeding_pump, pmda_japan
Philips Japan Recalls Integris Allura Flat Detector, Allura Centron, and Azurion Cardiac X-Ray Fluoroscopic Systems (Class II)
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
Philips Japan has initiated a Class II recall (No. 2-12881) for three stationary digital cardiac X-ray fluoroscopic diagnostic devices: Integris Allura Flat Detector, Allura Centron, and Azurion. This recall addresses a moderate safety risk that may affect device performance or patient safety. Healthcare facilities using these systems should immediately follow the manufacturer's field safety corrective action, which may involve inspection, software update, or part replacement, and contact Philips Japan for guidance.
Tags: philips, allura, azurion, cardiac_x_ray, class_ii_recall, pmda_japan
Class II Recall: Covidien Japan V-Loc90 & V-Loc180 Barbed Suture Closure Devices
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
Covidien Japan has issued a Class II recall (No. 2-12880) for its V-Loc90 and V-Loc180 barbed closure devices, which use polyglycomer and polyglyconate sutures respectively. The recall addresses a potential manufacturing defect that may compromise suture integrity, posing a risk of wound dehiscence or prolonged healing. Healthcare providers must immediately identify and quarantine affected lots, discontinue use, and arrange product return to the manufacturer.
Tags: recall, class_ii, suture, barbed_suture, covidien, pmda
PMDA Class II Recall: Sensitouch Synthetic Rubber Surgical Gloves (Non-Latex) by Toray Medical (Recall No. 2-12879)
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II recall for Sensitouch synthetic rubber surgical gloves manufactured by Toray Medical Co., Ltd. This moderate-risk recall addresses a potential quality defect that could compromise glove integrity. Healthcare providers must immediately identify and quarantine affected lots, cease use, and follow the manufacturer's return or disposal instructions as detailed in recall notice 2-12879.
Tags: surgical_gloves, class_ii_recall, non_latex, pmda, toray_medical, product_safety
Class II Recall of VITROS XT7600, 5600II, 5600, 4600 Clinical Chemistry Analyzers by Ortho Clinical Diagnostics in Japan
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
Japan's PMDA announced a Class II recall (No. 2-12877) for Ortho Clinical Diagnostics' VITROS XT7600, 5600II, 5600, and 4600 discrete clinical chemistry analyzers due to a potential performance issue. Affected devices may produce inaccurate results, necessitating a field correction. Healthcare facilities should immediately follow the manufacturer's notification for inspection, software update, or device replacement to mitigate patient risk.
Tags: pmda, class_ii_recall, vitros, clinical_chemistry_analyzer, ortho_clinical_diagnostics, safety
Class II Recall of Nemuri SCAN (NN-1530) Body Motion Sensor by Paramount Bed
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
Paramount Bed Co., Ltd. has initiated a Class II recall of its Nemuri SCAN (NN-1530) body motion sensor. The recall addresses a potential issue where the sensor may provide inaccurate movement detection, which could affect monitoring of patient sleep and activity. Healthcare facilities and users should stop using affected units and follow the manufacturer's instructions for return or replacement.
Tags: class_ii_recall, body_motion_sensor, paramount_bed, pmda, japan
Paramount Bed Recalls Nemuri SCAN (NN-1530) Body Movement Sensor – Class II
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12874) for the Nemuri SCAN (NN-1530) body movement sensor, manufactured by Paramount Bed Co., Ltd. The recall addresses a potential malfunction that could result in inaccurate detection of patient movements, posing a moderate safety risk. Healthcare facilities and distributors should immediately check affected devices and contact the manufacturer to arrange inspection and necessary corrective actions.
Tags: pmda, recall, class_ii, body_movement_sensor, paramount_bed, sleep_scan
[Class II] ジーシー ガスレーザー (炭酸ガスレーザ) - 株式会社ジーシー
2026-07-03 | Japan PMDA | Safety Communication | !! MEDIUM
Recall #2-12873: 炭酸ガスレーザ / ジーシー ガスレーザー by 株式会社ジーシー. Type: 医療機器.
Accuray CyberKnife Radiosurgery System and M6 Series Class II Recall in Japan (No. 2-12872)
2026-07-03 | Japan PMDA | Safety Communication | !! MEDIUM
Japan’s PMDA has issued a Class II recall (No. 2-12872) for the CyberKnife Radiosurgery System and CyberKnife M6 Series linear accelerator systems used in stereotactic radiotherapy, manufactured by Accuray Inc. The recall indicates a potential safety issue affecting these devices. Healthcare facilities in Japan operating these systems should immediately contact Accuray for corrective actions and follow the manufacturer’s instructions.
Tags: pmda_recall, class_ii, cyberknife, radiosurgery, linear_accelerator, stereotactic_radiotherapy, accuray