Browse Device Recalls
474 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 474 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 474 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Jan 31, 2020 | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not... | Class II | Cardinal Health 200, LLC |
| Jan 31, 2020 | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did no... | 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.