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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
May 20, 2014 ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSOR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOC... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed Femoral Pack , convenience pack include multiple components: Syringe... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed O.B. Pack convenience pack include multiple components: set up cov... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAF... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APP... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICA... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CU... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTIO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) C... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 13, 2014 Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonograph... Sterility of the device may be compromised due to unsealed pouch Class II CooperSurgical, Inc.
May 8, 2014 Anspach Pneumatic and Electric Motor Systems. Intended for cutting and sha... Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) wh... Class II The Anspach Effort, Inc.
Apr 24, 2014 DISP 9730951 STRL SPHERE, 5PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PACK 9731975 TUMOR RESECTION AXIEM CR Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BAG 9732315 MOUSE STERILE 15 PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733235, 100MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PATIENT TRACKER 9733534XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIOPSY NEEDLE KIT, 9733068, PASSIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INST 9731132 KIT CR REF FRAME DRIVER 5PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733608 SKULL MOUNT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733236, 150MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733066, BIOPSY, INT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DISP 9730950 STRL SPHERE, 1 PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INSTRUMENT TRACKER 9733533XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SHUNT KIT 9733605 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733607 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIT 9733516 2.9mm DRILL STERILE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 MOUSE 9732721 STERILE O-ARM 10PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 ENT PRGM 9734636 ADD FUSION NAV AxiEM Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 KIT, 9731427, THORACIC TACTILE PROBES Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RES. PACK 9733553 AxiEM S.M. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DRAPE 9732722 TUBE STERILE O-ARM 20PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Mar 4, 2014 Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800... Sterility of the product cannot be guaranteed. Class II Teleflex Medical
Mar 3, 2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... Class II Boston Scientific Corporation
Feb 19, 2014 Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon I... The possibility exists that an incomplete seal on the packaging compromised the sterility of the ... Class II Ethicon, 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.