Browse Device Recalls
4 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4 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 4 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 19, 2017 | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 0084527500... | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... | Class II | Fisher Diagnostics |
| May 19, 2017 | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determ... | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, li... | Class II | Fisher Diagnostics |
| Feb 5, 2014 | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator ... | A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Ap... | Class II | Fisher Scientific Co |
| Jun 5, 2013 | Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab... | The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presen... | Class II | Fisher Scientific Co |
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.