Browse Device Recalls

441 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 441 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 441 FDA device recalls.

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DateProductReasonClassFirm
Mar 16, 2021 ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 VAPORIZER VICKS 1.5GAL Item Number: 2354942 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Feb 25, 2021 In-View Clear Leggings Bulk Non-Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... Class II Cardinal Health 200, LLC
Feb 25, 2021 Femoral Angiography Drape Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... Class II Cardinal Health 200, LLC
Feb 25, 2021 Femoral Angiography Drape Bulk Non-Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... Class II Cardinal Health 200, LLC
Feb 25, 2021 In-View Clear Leggings Sterile Non-Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... Class II Cardinal Health 200, LLC
Feb 25, 2021 In-View Clear Leggings Sterile Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... Class II Cardinal Health 200, LLC
Feb 11, 2021 JUDKINS PACK Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) ... Class II Cardinal Health 200, LLC
Feb 9, 2021 Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 9, 2021 Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 9, 2021 McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Jan 19, 2021 Enteral Infusion Pump The potential for air appearing in the enteral feed pumping set tubing during set-up. Class II Cardinal Health 200, LLC
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 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
Sep 25, 2020 Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". ... Potential for the needle to detach from the cartridge after the bottom of the cartridge is twiste... Class II Cardinal Health 200, LLC
Sep 22, 2020 Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product U... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health 200, LLC
Sep 22, 2020 Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product ... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health 200, LLC
Aug 24, 2020 Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXI... The third-party brand latex micro surgical gloves packaged within specific custom packs may have ... Class II Alcon Research, LLC
Jul 30, 2020 KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intrana... Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treat... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... 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.