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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 15, 2020 | Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 15, 2020 | Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... | Class II | Cardinal Health 200, LLC |
| Jan 11, 2020 | AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 2XLARGE, Gown. Item Code 9578 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK XLARGE, Gown. Item Code 9548 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK LARGE, Gown. Item Code 9518 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
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.