Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Jan 15, 2021 ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Produc... An internal tubing component in the flow path was made with incorrect material which was not test... Class II Northgate Technologies, Inc.
Jan 15, 2021 Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71... An internal tubing component in the flow path was made with incorrect material which was not test... Class II Northgate Technologies, Inc.
Jan 7, 2021 Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, La... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004 Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, La... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium a... Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 ChemoPlus" Chemo Prep & Admin Kit, CT4025 Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 The PrisMax System Version II Hemodialysis Delivery System: Automatic Reposit... Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump As... Class II Baxter Healthcare Corporation
Jan 7, 2021 Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Heal... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Dec 30, 2020 Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product ... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: i... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 30, 2020 Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product c... complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis... Class II Baxter Healthcare Corporation
Dec 28, 2020 FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 m... Potential for the battery to lose its ability to be recharged. Class II Baxter Healthcare Corporation
Dec 21, 2020 Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Need... There were customer reports of separation between the tubing and Male Luer Lock Adaptor. Class II Baxter Healthcare Corporation
Dec 15, 2020 WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to rel... The connection between the massager and heat element can overheat causing smoke or spark, which m... Class II Wahl Clipper Corp
Dec 11, 2020 VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction o... VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usa... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 23, 2020 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... There is a potential software error during programming. Class II Baxter Healthcare Corporation
Nov 13, 2020 Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of c... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of con... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of conven... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type o... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 10, 2020 MiniCap Extended Life PD Transfer Set Potential for no-flow and leaks under the twist clamp. Class II Baxter Healthcare Corporation
Nov 5, 2020 RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressin... RevMedX Trauma Dressing is being recalled due to package seal integrity. Class II Medline Industries Inc
Oct 30, 2020 Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Num... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-0... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number:... Potential for a false-negative result. Class II Luminex Corporation
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field service engineers to s... Class II Luminex 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.