Single Use Rotatable Clip Fixing Device Model HX 201LR 135 — Class II medical device recall Z-1418-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-04-26, distributed nationwide. There have been complaints that the clip did not come out of the tube sheath during the procedure.
| Recall number | Z-1418-2023 |
|---|---|
| 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 | 2023-02-23 |
| Classified | 2023-04-20 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 14953170353106, 14953170353113, 14953170353120, 14953170353168 |
| Lot numbers | 1ZV, 23V, 24V |
| Model numbers | 135, 135L, 201LR, 201UR, HX-201LR-135, HX-201UR-135, HX-201UR-135L |
Product
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Reason for recall
There have been complaints that the clip did not come out of the tube sheath during the procedure.
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-1418-2023. 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.