Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Nov 6, 2018 IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000,... Table may drift in the roll position while in use Class II Deerfield Imaging, Inc.
Nov 6, 2018 IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, ... Table may drift in the roll position while in use Class II Deerfield Imaging, Inc.
Nov 6, 2018 Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... Firm is offering advice to customers experiencing challenges when validating the calibration curv... Class II The Binding Site Group, Ltd.
Nov 5, 2018 Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 There is a potential for the spring arm failure as a result of a broken tension rod (a component ... Class II Capintec Inc
Nov 5, 2018 enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for... Cosmetic imperfections on the surface of some lenses. Class II Bausch & Lomb Surgical, Inc.
Nov 5, 2018 Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 05... Potential for external blood leaks from the dialyzer header Class II Fresenius Medical Care Renal Therapies Group, LLC
Nov 5, 2018 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), ... The product was released into commercial distribution while subject to importation refusal. Class II COVIDIEN LLC
Nov 5, 2018 Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 There is a potential for the spring arm failure as a result of a broken tension rod (a component ... Class II Capintec Inc
Nov 2, 2018 CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for ... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusabl... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08,... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for u... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Produ... There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separ... Class II Virtual Imaging, Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket wit... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 GEM Coupler Forceps, GEM4183C, packaged individually. Potential presence of rust on Coupler Forceps (GEM4183C). Class II Baxter Healthcare Corporation
Nov 2, 2018 STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-track... The firm has detected a potential risk using the command. After releasing the command, the movem... Class II Stephanix
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket wit... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbe... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 Ascom Telligence Nurse Call System There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communica... Class II Ascom (US) Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket wit... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable ... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracke... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales re... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-st... Class II CIVCO Medical Instruments Co., Inc.
Nov 1, 2018 VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qua... The firm is extending their previous July 2018 recall to include additional product codes. Biased... Class II ORTHO-CLINICAL DIAGNOSTICS
Nov 1, 2018 SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of prod... The firm has become aware that due to a chemical reaction, the disinfectant/water preservative us... Class II LivaNova USA Inc.
Nov 1, 2018 Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated hi... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The Qu... The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorre... Class III R & D Systems, Inc.
Nov 1, 2018 Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high per... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in v... The firm is extending their previous July 2018 recall to include additional product codes. Biased... Class II ORTHO-CLINICAL DIAGNOSTICS
Nov 1, 2018 The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov... Experienced accelerated battery depletion and a shortened replacement interval due to latent inte... Class II Boston Scientific Corporation
Nov 1, 2018 VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro dia... The firm is extending their previous July 2018 recall to include additional product codes. Biased... Class II ORTHO-CLINICAL DIAGNOSTICS
Nov 1, 2018 Genesys Analytical Column, REF 01-05-0017 intended to be used with automated ... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high per... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with aut... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product C... This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dua... Class II COVIDIEN LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.0... Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller ... Class II Zimmer GmbH
Oct 31, 2018 NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size ... Screw is missing from the package Class II Zimmer Biomet, Inc.
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 FoundationOne CDx Test Results An incorrect test result for a single analyte may have been reported for up to 800 physician reports Class II Foundation Medicine, Inc.
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC

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.