Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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Date	Product	Reason	Class	Firm
Oct 20, 2022	regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenie...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery conve...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery c...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenienc...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208	Specific lots of FLXfit implants have internal components that may have been manufactured using s...	Class II	CoreLink LLC
Oct 20, 2022	regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenie...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; orth...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho sur...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery c...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery conveni...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenie...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 83009900...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery conven...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenienc...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenienc...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery conven...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 19, 2022	CMV IgM EIA, in vitro diagnostic.	Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (C...	Class II	Bio-Rad Laboratories, Inc.
Oct 18, 2022	Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000	Warehouse experienced temperature excursions in July and August 2021. It was determined that ther...	Class II	Atrium Medical Corporation
Oct 18, 2022	Hill-Rom Progressa Bed System	The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the...	Class II	Baxter Healthcare Corporation
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-...	Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of f...	Class II	Visionsense, Ltd.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IP...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Com...	Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of f...	Class II	Visionsense, Ltd.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Accelerate PhenoTest BC kit REF 10102018	Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) prob...	Class II	Accelerate Diagnostics Inc
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN00...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MM...	XXX	Class II	Visionsense, Ltd.
Oct 17, 2022	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.
Oct 17, 2022	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I...	There is a potential issue with short battery run-times on the affected intra-aortic balloon pump...	Class I	ARROW INTERNATIONAL Inc.

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.