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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

Clear
DateProductReasonClassFirm
Oct 11, 2023 Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multipl... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 VariSoft infusion set, Model Number 1002830 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 11, 2023 RANDOX Total Bilirubin. Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with To... Class II Randox Laboratories Ltd.
Oct 11, 2023 BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 VariSoft infusion set, Model Number 1002827 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 11, 2023 Curaplex manual resuscitators with integrated manometer, multiple accessory c... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal lif... May have increased water path restriction within the heat exchanger, leading to degraded heat exc... Class II Mc3 Inc
Oct 11, 2023 Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple ... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILT... Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... Class II Becton Dickinson & Company
Oct 11, 2023 Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multipl... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, mult... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multi... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, m... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Medline manual resuscitators with integrated manometer, multiple accessory co... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 VariSoft infusion set, Model Number 1002828 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-000-US with software ... Pump not detected as connected to controller due to software issue. Class II Abiomed, Inc.
Oct 10, 2023 VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Prod... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Co... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH... Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This is... Class I Maquet Medical Systems USA
Oct 10, 2023 VITROS XT 7600 Integrated System Product Code 6844461 Running Software Versio... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-040-US with software ... Pump not detected as connected to controller due to software issue. Class II Abiomed, Inc.
Oct 10, 2023 VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Cod... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 10, 2023 Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025 One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly cont... Class II Beaver Visitec International, Inc.
Oct 10, 2023 Stay Safe Cap Updating the labeling to include additional warnings and contraindications for potential side eff... Class II Fresenius Medical Care Holdings, Inc.
Oct 10, 2023 VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version... During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence ... Class II Ortho-Clinical Diagnostics, Inc.
Oct 9, 2023 Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), E... Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... Class II Philips Ultrasound, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessf... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of u... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 MED-810A Zemits NDPrime Laser products Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product ... Class II Advance-Esthetic LLC
Oct 9, 2023 Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccess... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... Class II Philips North America
Oct 9, 2023 Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... Class II Philips Ultrasound, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America 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.