Browse Device Recalls
32 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 32 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 32 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2015 | Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable to... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | 200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on Endo... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
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.