Browse Device Recalls
22 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 22 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 22 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 20, 2016 | Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonos... | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric... | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatri... | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems 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.