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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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 16, 2018 Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurova... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovasc... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascu... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurov... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascula... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones ... CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, righ... Class II In2bones USA, LLC
Jul 16, 2018 RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 ... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones ... CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, righ... Class II In2bones USA, LLC
Jul 16, 2018 Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovas... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 1... The product was mislabeled as containing the incorrect type of suture. Class II Valeris Medical, LLC
Jul 16, 2018 Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular ... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS)... Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patien... Class II Intuitive Surgical, Inc.
Jul 16, 2018 Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurov... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neur... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cob... Sample material may potentially come in contact with the pipetting nozzle during operation of cob... Class II Roche Diagnostics Corporation
Jul 16, 2018 Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular ... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurova... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is ... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is... Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... Class II Siemens Healthcare Diagnostics, Inc.
Jul 16, 2018 INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular ... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurova... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular an... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovasc... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation
Jul 16, 2018 Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neuro... There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... Class II Philips Electronics North America Corporation

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.