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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

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
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Numb... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2... Notes associated with prescription are not printed to the prescription or to the patient chart. Class II Picis Inc.
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Produ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a wat... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Produc... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a wa... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a w... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Numbe... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 20, 2013 TDHistology/Cytology Classification name: Calculator/data processing modul... A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... Class III Technidata S.A.
Jun 20, 2013 TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurp... Research Use Only (RUO) parameters were included in TEG 5000 User Manual. Class II Haemonetics Corporation
Jun 19, 2013 VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Disp... Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems... Class II Siemens Healthcare Diagnostics, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The a... GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS... Class II GE Healthcare, LLC
Jun 19, 2013 Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect... Class II Philips Healthcare Inc.
Jun 19, 2013 DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, ... Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolut... Class II Carestream Health Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands ar... Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particul... Class II Edwards Lifesciences, LLC
Jun 19, 2013 Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Pro... Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots Class III Beekley Corporation
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilita... Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly ... Class II Biosense Webster, Inc.
Jun 18, 2013 ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for v... Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant -... Class II Aesculap, Inc.
Jun 18, 2013 LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE... Hospira has received reports of customers experiencing air-in-line alarms related to administrati... Class II Hospira Inc.
Jun 18, 2013 CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per ca... There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord s... Class II Invacare Corporation
Jun 17, 2013 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo... CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope... Class I CareFusion 303, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboG... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 17, 2013 Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 16, 2013 The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging ... Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading informat... Class II Stryker Instruments Div. of Stryker Corporation
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux Inc
Jun 14, 2013 bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... A product issue has been identified for customers using software version 6.01 and are interfaced ... Class II Biomerieux 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.