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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.

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DateProductReasonClassFirm
Jul 26, 2022 Vanta Clinician Programmer Application, Model A71200. For programming of the... Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200... Class II Medtronic Neuromodulation
Jul 26, 2022 Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Products were released to customers prior to the approval and release of a test report authorizin... Class II BALT USA, LLC
Jul 26, 2022 Vanta Clinician Programmer Application, Model A71200. For programming of the... Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unex... Class II Medtronic Neuromodulation
Jul 25, 2022 NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701 The sterile barrier may be compromised. Class II Stradis Medical, LLC dba Stradis Healthcare
Jul 25, 2022 NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 The sterile barrier may be compromised. Class II Stradis Medical, LLC dba Stradis Healthcare
Jul 25, 2022 Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Due to the presence of a burr which may cause an aspiration risk to patient during surgical proce... Class II Nobel Biocare
Jul 25, 2022 NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700 The sterile barrier may be compromised. Class II Stradis Medical, LLC dba Stradis Healthcare
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEM... One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix ... Class II Corin Ltd
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100 There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, RE... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A precon... The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... Class II Maquet Medical Systems USA
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, ... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 p... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack,... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 21, 2022 Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for ... Device does not meet regulatory requirements of stability while stationary, which requires mechan... Class II Getinge Usa Sales Inc
Jul 21, 2022 Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028... The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an ... Class II Unomedical A/S
Jul 21, 2022 Medline CHEST TUBE REORDER NO: DYNJ36762A Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Co... Class II Medline Industries Inc.
Jul 20, 2022 FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 Increased occurrence rate of false positive results, lead to a false positive sample result that... Class II Qiagen Sciences LLC
Jul 20, 2022 iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample ... Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR A... Class II Alcor Scientific, Inc.
Jul 20, 2022 EVIS EXERA III Bronchovideoscope The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned t... Class II Aizu Olympus Co., Ltd.
Jul 20, 2022 NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. There is a potential of no result leading to possible delayed result due to contamination of extr... Class II bioMerieux, Inc.
Jul 20, 2022 therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 Increased occurrence rate of false positive results, lead to a false positive sample result that... Class II Qiagen Sciences LLC
Jul 20, 2022 therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 Increased occurrence rate of false positive results, lead to a false positive sample result that... Class II Qiagen Sciences LLC
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. Incorrect optical calibration Class II Abbott Molecular, Inc.
Jul 19, 2022 VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: ... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. Screws mounting an internal power supply may come loose during shipping resulting in increased ri... Class II Myolyn Inc.
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-1... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 18, 2022 Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for... Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potentia... Class II Siemens Healthcare Diagnostics, Inc.
Jul 18, 2022 BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... Incorrect expiration date listed on the product labels. The expiration date listed on the product... Class II Becton Dickinson & Company
Jul 15, 2022 DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release... The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap... Class II DeRoyal Industries Inc
Jul 15, 2022 (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity ... Inaccurate Distance and Area measurements with use of Global Stack viewport. Class II GE Healthcare, LLC
Jul 15, 2022 Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmenta... Potential for the incorrect screw to be included in the package. Class II Aesculap Implant Systems 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.