Browse Device Recalls
960 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 960 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 960 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 19, 2020 | Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and t... | Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay p... | Class II | EHOB, Inc. |
| 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 |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N | 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 NONREINF SURGICAL GOWN 4XL, Item Code 9599 | 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 LG 2 TWL, Item Code ASG9515 | 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, Item Code 9541 | 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 XL, Item Code 9548NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA | 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 L, Item Code 90270NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Nov 4, 2019 | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr... | False positive results due to potential contamination of reagent. | Class II | Immuno-Mycologics, Inc |
| Aug 1, 2019 | Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 ... | The firm has become aware that the sensor cover, a component of the single-use navigation kit ma... | Class II | Imactis |
| Jun 3, 2019 | The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... | Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua... | Class II | Roche Diagnostics Corporation |
| May 29, 2019 | Liberty Cycler Cassettes (a disposable cassette that is intended to be used t... | Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler... | Class II | Fresenius Medical Care Renal Therapies Group, 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.