Browse Device Recalls

432 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 432 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 432 FDA device recalls.

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Date	Product	Reason	Class	Firm
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
Jun 4, 2020	Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - ...	Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne...	Class II	Cardinal Health 200, LLC
Jun 4, 2020	Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usa...	Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne...	Class II	Cardinal Health 200, LLC
Apr 20, 2020	Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product ...	Three products requiring refrigerated storage conditions were incorrectly stored outside of appro...	Class II	Cardinal Health Inc.
Apr 20, 2020	B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is...	Three products requiring refrigerated storage conditions were incorrectly stored outside of appro...	Class II	Cardinal Health Inc.
Apr 20, 2020	Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere P...	Three products requiring refrigerated storage conditions were incorrectly stored outside of appro...	Class II	Cardinal Health Inc.
Feb 4, 2020	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo...	Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u...	Class II	Deroyal Industries, Inc. Lafollette
Feb 4, 2020	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo...	Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u...	Class II	Deroyal Industries, Inc. Lafollette
Feb 4, 2020	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo...	Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u...	Class II	Deroyal Industries, Inc. Lafollette
Feb 4, 2020	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo...	Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u...	Class II	Deroyal Industries, Inc. Lafollette

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.