Colonoscope: for endoscopy and endoscopic surgery within the lower… — Class II medical device recall Z-0329-2024
Ongoing recall by Aizu Olympus Co., Ltd., reported 2023-11-29, distributed nationwide. Channel air drying process was not validated, and that a small percentage of scopes returned to customers afte
| Recall number | Z-0329-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aizu Olympus Co., Ltd., Aizuwakamatsu, N/A, Japan |
| Recall initiated | 2023-09-25 |
| Classified | 2023-11-17 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,344 units |
| UPC / GTIN / UDI-DI | 04953170305115, 04953170305139, 04953170305153, 04953170305177, 04953170307621, 04953170307638, 04953170307645, 04953170307652, 04953170307669, 04953170307690, 04953170307706, 04953170312397, 04953170312410, 04953170334160, 04953170334184, 04953170339585, 04953170339608, 04953170339639, 04953170339653 |
| Model numbers | 510, CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL |
Product
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
Reason for recall
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
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-0329-2024. 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.