Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended… — Class II medical device recall Z-1987-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-06-28, distributed nationwide. Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clip
| Recall number | Z-1987-2023 |
|---|---|
| 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 | 2023-05-04 |
| Classified | 2023-06-21 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 340 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170385919 |
| Lot numbers | 24K, 27K, 29K, 2XK, 2YK |
| Model numbers | HX-202LR.A |
Product
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Reason for recall
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a 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-1987-2023. 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.