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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

3,282 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.

Clear
DateProductReasonClassFirm
Oct 8, 2014 Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Open Heart Pack, catalog #900-2618 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perf... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Universal Drainage Tray, Catalog number 900-032. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Urology Pack, Catalog # 900-868 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-2038. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform pat... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Skin Staple Removal, Catalog number 900-782. Used by medical staff to perf... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-1488. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Wound Closure Tray I, Catalog number 900-063. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 O.R. Towels, Catalog number 900-629. Used by medical staff to perform pati... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 OB Pack, Catalog number 900-1717. Used by medical staff to perform patient... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 OB Pack, catalog #900-254 Used by medical staff to perform patient care pr... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Femoral Pack, catalog #900-2164 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog number 900-403. Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Sep 30, 2014 Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Kn... Packaging of a device was compromised Class II Signal Medical Corporation
Sep 30, 2014 CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ... Incorrect expiration date printed on the MILEX PESSARY KIT packaging Class III CooperSurgical, Inc.
Sep 30, 2014 CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode... Incorrect expiration date printed on the MILEX PESSARY KIT packaging Class III CooperSurgical, Inc.
Sep 3, 2014 Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB... Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... Class II Teleflex Medical
Sep 3, 2014 Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 102... Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... Class II Teleflex Medical
Aug 27, 2014 GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... Due to an anomaly in the packaging process, it is possible that a defective seal could be present... Class II Gyrus Medical, Inc
Aug 26, 2014 Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) ... Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at... Class II Bard Peripheral Vascular Inc
Aug 14, 2014 Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ ... Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unope... Class II Biomedix, Inc.
Aug 6, 2014 B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... Class II B. Braun Medical, Inc.
Aug 5, 2014 DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, ... Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves... Class II Catheter Connections, Inc.
Aug 1, 2014 CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STO... A pinhole leak identified in the packaging of the recalled product potentially could compromise t... Class II Civco Medical Instruments Inc
Jul 22, 2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105L... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG ... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, 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.