Browse Device Recalls
65 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 65 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 65 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2021 | Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stab... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLoc... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" St... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Apr 15, 2020 | SureStep Foley Tray System - Product Usage: Intended for use in the drainage ... | There is potential for a white paper-type residue attached to the catheter. | Class II | C.R. Bard Inc |
| Jan 13, 2020 | The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing s... | Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device whic... | Class II | C.R. Bard Inc |
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.