Colonoscope — Class II medical device recall Z-1213-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-03-06, distributed nationwide. Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physic
| Recall number | Z-1213-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-01-11 |
| Classified | 2024-02-29 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 28 |
| UPC / GTIN / UDI-DI | 04953170416118 |
| Serial numbers | 2000569, 2001007, 2101185, 2101301, 2101313, 2101860, 2102339, 2102634, 2102740, 2103215, 2103257, 2103483, 2103614, 2103674, 2203899, 2203915, 2204096, 2204400, 2204659, 2204820, 2205238, 2205684, 2206065, 2206501, 2307200 and 3 more |
| Model numbers | PCF-HQ190L |
Product
Colonoscope, Model Number PCF-HQ190L.
Reason for recall
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
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-1213-2024. 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.