Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
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
Oct 9, 2023	Spectral CT on Rails, Software Version 5.1.0, Model Number 728334	This recall is part of a 2-issue recall for the same system. When using the IVC needle position b...	Class II	Philips North America
Oct 9, 2023	Compress Device Short Anchor Plug, 14 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, 24 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, 26 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 6, 2023	D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.	Customer complaint received that reported the applier failed during surgery. The applier did not ...	Class II	Peter Lazic Gmbh
Oct 6, 2023	CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles	one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite...	Class II	Young Dental Manufacturing I, LLC
Oct 6, 2023	ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot...	Users of the patient positioning system ORION System can be faced with a sudden short-term accele...	Class II	LEONI CIA CABLE SYSTEMS
Oct 6, 2023	D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.	Customer complaint received that reported the applier failed during surgery. The applier did not ...	Class II	Peter Lazic Gmbh

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.