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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,282 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,282 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 3,282 FDA device recalls.

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DateProductReasonClassFirm
Jun 7, 2017 DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... Class II DeRoyal Industries Inc
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
May 25, 2017 Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part... Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received ... Class II Atrium Medical Corporation
May 22, 2017 TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE There is a potential risk of puncture to the packaging material which can compromise the devices ... Class II Somatex Medical Technologies GmbH
May 22, 2017 DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-... FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit b... Class III Euro Diagnostica AB
May 17, 2017 QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dres... Packaging breach may compromise sterility Class II Z-Medica, LLC
May 11, 2017 Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G A... Argon Medical has received a complaint from one of their distributors of a potential packaging de... Class II Argon Medical Devices, Inc
May 10, 2017 Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Cod... Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use we... Class II ConvaTec, Inc
May 9, 2017 Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for H... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blu... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pre... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Fea... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
Apr 28, 2017 R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48C... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 4.5 BROAD SCP PLT 26-H STER Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMD... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthr... Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen... Class II Zimmer Biomet, Inc.
Apr 28, 2017 FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM ... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 13... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L ... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 25, 2017 StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. ste... StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. Class II Bard Access Systems Inc.
Apr 25, 2017 ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a qu... False susceptible results Class II BioMerieux SA
Apr 20, 2017 Microfil Composite Instruments are packaged in an unsealed plastic sleeve, wh... Microfil Composite Instruments were distributed with a sterile symbol on their packaging label in... Class II Almore International Inc
Apr 13, 2017 ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative techn... QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo... Class II BioMerieux SA
Apr 13, 2017 Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ... Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i... Class II Medtronic Sofamor Danek USA Inc
Apr 13, 2017 ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative tec... QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo... Class II BioMerieux SA
Apr 13, 2017 Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gent... Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek pac... Class II Zimmer Biomet, Inc.
Apr 10, 2017 CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... Class II CooperSurgical, Inc.
Mar 30, 2017 AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... Class II Abbott Medical Optics Inc. (AMO)
Mar 29, 2017 Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. Class III Teleflex Medical

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.