Olympus — Class II medical device recall Z-0897-2016
Terminated recall by Integrated Medical Systems Inc, reported 2016-03-02, distributed nationwide. If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the di
| Recall number | Z-0897-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integrated Medical Systems Inc, Birmingham, AL, United States |
| Recall initiated | 2016-01-20 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 5 instruments |
| Reason classes | device malfunction |
| Serial numbers | 2112612, 2123053, 2337714, 2337727, 2338700 |
| Model numbers | PCF-160AL |
Product
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
Reason for recall
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0897-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.