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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

3,192 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,192 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 3,192 FDA device recalls.

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DateProductReasonClassFirm
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
Apr 14, 2014 TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), ... The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that... Class II Tenex Health Inc
Mar 26, 2014 Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an ele... During packaging verification testing, a failure occurred due to cuts in the packaging potentiall... Class II Stryker Instruments Div. of Stryker Corporation
Mar 24, 2014 AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5... There is a possibility the sterile packaging may fail before the expiration date specified on the... Class II Soma Access Systems LLC
Mar 4, 2014 Heart Mate II Pocket Controllers removed from packaging Product Usage: ... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Feb 25, 2014 Apollo" Knee System: APOLLO PATELLA SZ0 28MM R A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL P... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FL... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
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.
Feb 19, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... Class II Gyrus Medical, Inc
Feb 7, 2014 MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: ... Tyvek packaging may be worn, causing loss of package integrity. Class II Biocardia, Inc.
Feb 7, 2014 FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... Packaging error -- two different types and sizes of acetabular liners used during hip replacement... Class II Djo Surgical
Feb 3, 2014 Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalo... Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angl... Class II Stryker Howmedica Osteonics Corp.
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... Class II Coltene Whaledent Inc
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock ... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Nov 5, 2013 DIST LAT FEM LOCK PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 ITST THREADED GUIDE PIN Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, RT. Based on a review of historic packaging validations, it was determined that a subset of product p... 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.