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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

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Apr 19, 2013 Centricity Enterprise Archive is a software product for receiving, archiving ... GE Healthcare has become aware of a potential data loss issue associated with empty path names re... Class II Ge Healthcare It
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... Class II OrthoPediatrics Corp
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... Class II OrthoPediatrics Corp
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... Class II OrthoPediatrics Corp
Apr 18, 2013 Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI ... Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical micros... Class II Carl Zeiss Meditec, Inc.
Apr 18, 2013 Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile ... Cook Medical has received a small number of complaints related to the delivery system for the Zil... Class I Cook, Inc.
Apr 18, 2013 Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 4... Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been d... Class II Synthes USA HQ, Inc.
Apr 18, 2013 Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile... Cook Medical has received a small number of complaints related to the delivery system for the Zil... Class I Cook, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 The Constellation Vision System Pneumatic Handpiece. Indicated for both an... Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, prod... Class II Alcon Grieshaber AG
Apr 17, 2013 Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube use... The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. Class I Bryan Medical Inc
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrum... Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefor... Class II BioMerieux SA
Apr 17, 2013 Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part ... Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a ... Class II Beckman Coulter Inc.
Apr 17, 2013 Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Nu... A complaint investigation has found that product fractures can occur at the distal end of the cat... Class II Xlumena, Inc.
Apr 16, 2013 Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereT... The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG11101... Class II Alere San Diego, Inc.
Apr 16, 2013 BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended... Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / l... Class II Bard Peripheral Vascular Inc
Apr 16, 2013 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical lase... A defect in the controller board can lead to the condenser to the video monitor becoming too warm... Class II Ziemer Usa Inc
Apr 15, 2013 Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synth... Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive ... Class II Synthes USA HQ, Inc.
Apr 15, 2013 Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; sing... Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbili... Class II Cypress Medical Products LLC
Apr 15, 2013 Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Cont... The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which ori... Class III Bio-rad Laboratories, Inc.
Apr 15, 2013 Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for... Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or ... Class II Hill-Rom, Inc.
Apr 15, 2013 DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusab... Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 15, 2013 DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs... The firm is recalling these power cables due to a latent design reliability issue and the potenti... Class II Medrad Inc
Apr 15, 2013 Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, I... Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core,... Class II Philips Medical Systems (Cleveland) Inc
Apr 15, 2013 FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic ... AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Gluco... Class I Abbott Diabetes Care, Inc.
Apr 12, 2013 LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk n... Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ... Class II Ethicon Endo-Surgery Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Tra... Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ... Class II Ethicon Endo-Surgery Inc
Apr 12, 2013 Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... Class III Covidien LLC
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 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-ST... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID... On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... Class III Covidien LLC
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
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 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Pro... Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ... Class II Ethicon Endo-Surgery Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitr... Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pur... Class II Paa Laboratories Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push ... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapa... Product coatings require 510K approval. Class II Progressive Medical 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.