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Vehicle Safety

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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
May 20, 2014 OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARG... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS RE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDP... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CAR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" 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) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
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 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw Syste... Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression ... Class II Small Bone Innovations
May 19, 2014 VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 ... This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that de... Class II Integra LifeSciences Corp.
May 19, 2014 CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 Blade can shift during shipping which makes the product ineffective. Class II KCI USA, Inc.
May 19, 2014 V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. ... ECG interpretation feature issues. False measurements reported when the algorithm cannot determi... Class II Mindray DS USA, Inc. dba Mindray North America
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 Shaver Handpiece Sterilization Tray. Model number 272-700-000. For steriliza... STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) d... Class II Stryker Endoscopy
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 16, 2014 Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT200... The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate ... Class I Ventlab 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.