Browse Device Recalls
407 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 407 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 407 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2016 | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | Software malfunction that results in incorrect generation or display of error codes. | Class II | Olympus Corporation of the Americas |
| Jun 23, 2016 | OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector | New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when usi... | Class II | Olympus Corporation of the Americas |
| Mar 15, 2016 | EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus v... | New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised man... | Class II | Olympus Corporation of the Americas |
| Jan 8, 2016 | Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: T... | Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenos... | Class II | Olympus Corporation of the Americas |
| Nov 17, 2015 | Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm... | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. E... | Class II | Olympus Corporation of the Americas |
| Sep 11, 2015 | MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a con... | small puncture marks in a sterile package for an accessory to an Olympus device | Class II | Olympus Corporation of the Americas |
| Aug 21, 2015 | EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscop... | Insufficient information for specific cleaning accessories used for the cleaning and reprocessing... | Class II | Olympus Corporation of the Americas |
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.