Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Nov 4, 2020 Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to bre... All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface betwee... Class II K2M, Inc
Nov 3, 2020 STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SUR... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Bio... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biops... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy ... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Val... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-1... Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which co... Class II NEOSTEO
Nov 3, 2020 Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed o... It has been determined that the software distributed with the retinal camera may delete patient i... Class II Kowa Optimed Inc
Nov 3, 2020 Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The... Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due ... Class II K2M, Inc
Nov 3, 2020 STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Wa... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleanin... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corp... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascu... This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF... Class II Boston Scientific Corporation
Nov 2, 2020 MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Produ... XXX Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures ... Manufacturing packaging error. Class II Smith & Nephew, Inc.
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Prod... XXX Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The... Products do not meet stability criteria and may impact results. Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Produc... Products do not meet stability criteria and may impact results. Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Num... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-0... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.