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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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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Jul 1, 2014 Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... Class II Biomet, Inc.
Jun 25, 2014 Merci Retriever Intended to restore blood flow in the neurovasculature by ... Merci Retrievers were shipped to US customers past their expiration date, even though they were l... Class II Concentric Medical Inc
Jun 25, 2014 Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... The case label correctly states partial rebreather but the insert label incorrectly states non-re... Class II Salter Labs
Jun 25, 2014 BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abut... Identifiers on the label are correct but the label has the incorrect color coding. Class II Biomet 3i, LLC
Jun 23, 2014 Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000... Product was held at temperature above the labeled recommended storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... Class II Biomet, Inc.
Jun 20, 2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... Class II Laser Peripherals LLC
Jun 13, 2014 Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... Class II Aesculap, Inc.
Jun 12, 2014 Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREA... Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 we... Class II Zimmer Manufacturing B.V.
Jun 11, 2014 Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aero... Bottles did not provide positive signals within the time frame of the quality control specificati... Class II Remel Inc
Jun 9, 2014 Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal ... An oversight in the implementation of the design change record resulted in outdated components be... Class II Arthrosurface, Inc.
Jun 9, 2014 MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... Laser aperture label was not affixed to device prior to shipment in the US. Class II Nidek Inc
Jun 9, 2014 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These device... Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product con... Class II 3M Company - Health Care Business
Jun 5, 2014 Calcium Hydroxide Powder, USP For use in root canal therapy by health care... One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed... Class II Axcentria Pharmaceuticals, LLC
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
May 30, 2014 Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa... Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o... Class III Alere San Diego, Inc.
May 29, 2014 Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius ... The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found... Class II Synthes, Inc.
May 28, 2014 Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculati... Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1,... Class II Baxter Corporation Englewood
May 23, 2014 RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Me... Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the ... Class II Teleflex Medical
May 21, 2014 cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filt... Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... Class II Roche Diagnostics Operations, Inc.
May 21, 2014 cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filt... Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... Class II Roche Diagnostics Operations, Inc.
May 21, 2014 Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software... Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... Class II Roche Diagnostics Operations, Inc.
May 21, 2014 BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catal... A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 322... Class III Becton Dickinson & Co.
May 20, 2014 FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed Major Laparotomy Pack , convenience pack include multiple components... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN S... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABS... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) T... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH L... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WIT... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREA... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) A... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE U... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16o... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCE... 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 CONTENTS: (1) SOLUTION SURGICAL D... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SH... Customed has determined that there is the possibility that packaging integrity may be compromised... 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.