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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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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 15, 2013 Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Prod... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 8, 2013 DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 ... LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove pa... Class III DePuy Orthopaedics, Inc.
Apr 30, 2013 FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... Class II American Optisurgical Inc
Apr 12, 2013 Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Colopla... Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorre... Class II Coloplast Manufacturing US, LLC
Apr 12, 2013 BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptiv... In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... Class II Becton Dickinson & Co.
Apr 12, 2013 BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive di... In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... Class II Becton Dickinson & Co.
Apr 8, 2013 Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... Class II Ethicon Endo-Surgery Inc
Mar 28, 2013 Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile uri... Sterile packaging may be compromised. Class II Teleflex Medical
Mar 26, 2013 Presource PBDS, General Laparoscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Knee Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Extremity, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Total Knee, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Major Abdominal, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Total Joint, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Total Hip, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Gyn Laparoscopy Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood L... Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Hand, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Knee Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Shoulder Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Shoulder Procedure, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 25, 2013 Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... Class II Stryker Howmedica Osteonics Corp.
Mar 8, 2013 Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a p... Class II Ormco/Sybronendo
Feb 26, 2013 Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod... Incorrect size was printed on the outer product packaging. Class II Cooper Surgical, Inc.
Feb 7, 2013 Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. Class II Myco Medical Supplies Inc
Feb 4, 2013 Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... Incorrect packaging of regular set and fast set cartridges. Class III Ultradent Products, Inc.
Feb 4, 2013 Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... Incorrect packaging of regular set and fast set cartridges. Class III Ultradent Products, Inc.
Jan 14, 2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 14, 2013 BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 3, 2012 SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protect... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, 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.