Browse Device Recalls
2,609 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,609 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 2,609 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 9, 2023 | Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitat... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quan... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitat... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 5, 2023 | abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF B... | Incorrect expiration date on product label. The manufacturing date was listed as the expiration ... | Class III | S & MOHR AMERICA, S.A. DE C.V. |
| Jan 4, 2023 | Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair... | Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). | Class II | Bard Peripheral Vascular Inc |
| Jan 4, 2023 | WishBone Medical Smart Correction Dual Joint Express Struts, external skeleto... | Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint E... | Class II | Wishbone Medical, Inc. |
| Jan 3, 2023 | Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)... | Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher t... | Class II | Western/Scott Fetzer Company |
| Jan 3, 2023 | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloop... | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, bu... | Class III | Owens & Minor Distribution, 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.