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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

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

Clear
DateProductReasonClassFirm
Oct 20, 2022 regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE , NU00974F, Item Number 800769006; 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 LAMINECTOMY, NU01140, Item Number 900940; 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 VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenien... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenie... 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 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 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 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 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 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 HAND PACK, OR00594K, Item Number 800243011; 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, OR00049Q, Item Number 880044017; ortho surgery ... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard CATARACT, EY00450L, Item Number 880295012; eye 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, NU00698I, Item Number 800246009; neuro surgery convenience kit Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases wher... Class II CooperSurgical, Inc.
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 ¿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 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 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 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 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 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 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 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 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 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 GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ... Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller pri... Class II Steris Corporation
Oct 17, 2022 Accelerate PhenoTest BC kit REF 10101018 Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) prob... Class II Accelerate Diagnostics 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 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 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 VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MM... XXX Class II Visionsense, Ltd.
Oct 14, 2022 GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 Procedure Instruments with erroneous unit carton labels. Class II Sonendo Inc
Oct 14, 2022 Philips Laser System, REF: LAS-100. Used in minimally invasive interventiona... Laser System may detect Error 106 or Error 108 System Failures that will cause the system to ente... Class II Spectranetics Corporation
Oct 14, 2022 Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and ... The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a pa... Class II Getinge Usa Sales Inc
Oct 14, 2022 Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10M... Due to a defect in the outer pouch sterile seal Class II Medtronic Navigation, Inc.
Oct 14, 2022 GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Sin... Procedure Instruments with erroneous unit carton labels. Class II Sonendo Inc
Oct 13, 2022 EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, wh... Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. Class II Boston Scientific Corporation
Oct 13, 2022 VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides F... Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathem... Class II Ortho-Clinical Diagnostics, Inc.
Oct 13, 2022 BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid iden... Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) ... Class II Becton Dickinson & Co.
Oct 12, 2022 Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use Abbott has identified potential performance issues for the Alinity m System software version 1.6.... Class II Abbott Molecular, Inc.
Oct 12, 2022 OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-... The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. Class II Novapproach Spine 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.