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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Sep 10, 2018 -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) ... Firm identified an issue in the manufacturing process which might contribute to elevated rates of... Class II BioFire Diagnostics, LLC
Sep 7, 2018 APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas... The firm identified customer sites where modules which the safety pacemaker label is missing. Inf... Class II Abbott Laboratories, Inc
Sep 6, 2018 CryoPatch SG Pulmonary Hemi-Artery, 1 graft The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product l... Class II CryoLife, Inc.
Aug 28, 2018 Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... Certain HVAD System Controller units may not meet the labeled standard for protection against wat... Class II Heartware, Inc.
Aug 24, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product... The firm has identified customer sites where there are modules on which the safety pacemaker labe... Class II Inpeco S.A.
Aug 24, 2018 TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tra... Modifications to the specification were not appropriately qualified through the company's design ... Class II TriMed Inc.
Aug 23, 2018 AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated... The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label... Class II Tosoh Bioscience Inc
Aug 16, 2018 BioMend Extend, REF# 0142Z, Synthetic bone grafting material. There is a possibility that the product was packaged in the wrong box. Specifically, the product... Class III Collagen Matrix, Inc.
Aug 16, 2018 Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec... Class III Medtronic Vascular
Aug 14, 2018 APTIO CENTRIFUGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO 9000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ... The product may be counterfeit and could have microbial issues. Class II Lens.com
Aug 14, 2018 APTIO RACK OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB - REFRIGERATED STORAGE MODULE 15000 The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB - REFRIGERATED STORAGE MODULE 9000 The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO INPUT/OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 STREAMLAB CORE UNIT / LYNX WITH IOM The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO RACK INPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2018 APTIO 15000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to p... Class II Siemens Healthcare Diagnostics, Inc.
Aug 10, 2018 Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... Vials of the autoHDL/LDL Calibrator were shipped without a vial label. Class III Medtest Holdings, Inc.
Aug 8, 2018 ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic ... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Aug 8, 2018 ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic U... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Aug 8, 2018 Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:008... The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging ... Class II Philips North America LLC
Aug 8, 2018 ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mm... Two units in distribution were found to be mislabeled on the vial cap with the incorrect part num... Class II Implant Direct Sybron Manufacturing, LLC
Aug 7, 2018 ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, R... The incorrect device was packaged in the vial. Class II Implant Direct Sybron Manufacturing, LLC
Aug 3, 2018 Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol i... Expiration date incorrectly listed on the label Class II Zimmer Biomet, Inc.
Aug 2, 2018 Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon... The product is labeled with an incorrect expiration date. Class III Acumedia Manufacturers, Inc.
Aug 2, 2018 Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media... Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe... Class III Acumedia Manufacturers, Inc.
Aug 1, 2018 Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ... Potentially counterfeit products in/and counterfeit packaging were imported to the U.S. Class II Allied Vision Group Inc
Jul 30, 2018 Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P... The item is labeled as an 8.3mm, but it is actually a 12 mm. Class II Zimmer Biomet, Inc.
Jul 30, 2018 ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product ... Products are labeled with an incorrect expiration date Class II Arrow International Inc
Jul 27, 2018 ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for ... Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. Class II Synvasive Technology Inc
Jul 25, 2018 Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Pro... There was a potential that a 25-gauge infusion cannula may be included within the procedure pak i... Class II Alcon Research LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning Sterilization Protocol for Trillia... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 16, 2018 Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 1... The product was mislabeled as containing the incorrect type of suture. Class II Valeris Medical, LLC
Jul 13, 2018 Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 86... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... The product was mislabeled with the incorrect label. Class III Smiths Medical ASD Inc.
Jul 13, 2018 Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns V... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central m... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation
Jul 13, 2018 Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066... Philips has received several reports in which monitors with lithium ion batteries that had exceed... Class II Philips Electronics North America Corporation

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.