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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

1,003 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,003 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 1,003 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 29, 2015 Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Muco... Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... Class II Richard-Allan Scientific Company
Apr 24, 2015 D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with... A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fe... Class II GE Healthcare
Mar 27, 2015 CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous... There is a potential for a hole to be present in the outer tray of a limited number of pain contr... Class II B. Braun Medical, Inc.
Mar 26, 2015 Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound o... The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not cons... Class II PhotoMedex, Inc.
Mar 23, 2015 ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. Siemens internal investigation confirmed that current contamination avoidance settings do not pre... Class II Siemens Healthcare Diagnostics, Inc.
Mar 10, 2015 FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE,... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Feb 11, 2015 Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... Class II Sybron Dental Specialties
Dec 18, 2014 Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positi... Class II Roche Diagnostics Operations, Inc.
Dec 17, 2014 Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in ... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in ske... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 Metasul Femoral Head - A modular head component is used in conjunction with a... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 Metasul Femoral Head - indicated for total hip arthroplasty for treatment of... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Dec 17, 2014 CoCr Femoral Head - A modular head component is used in conjunction with a fe... Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... Class II Zimmer Gmbh
Nov 26, 2014 GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS... Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the w... Class II Getinge Disinfection Ab
Oct 21, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile... Class II Gyrus Acmi, Incorporated
Oct 8, 2014 Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Cataract Pack, Catalog # 900-944 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 Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Extremity PACK, catalog #900-2615 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 Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Chole Pack, Catalog number 900-1688. 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 Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Uretheral Catheter Tray, Catalog number 900-278. 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 Cesarean Pack, Catalog number 900-1689. 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 Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Premium OB Pack, Catalog number 900-1297. 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 Open Heart Tray, Catalog number 900-1196C 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 Laparoscopy Pack, Catalog number 900-1967. 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 Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Total Hysterectomy, catalog #900-2415 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 Cystoscopy Pack III, catalog #900-2482 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 Fanfold Drape, Catalog number 900-633. 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 Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, Catalog number 900-149. 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 Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to pe... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-1176. 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 Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, 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.