Brand Name: Single Use Ligating Device Product Name: Olympus… — Class I medical device recall Z-0570-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2025-12-03. Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to b
| Recall number | Z-0570-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-10-30 |
| Classified | 2025-11-25 |
| Reported by FDA | 2025-12-03 |
| Quantity | 7,803 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170368615 |
| Model numbers | HX-400U-30 |
Product
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Reason for recall
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
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-0570-2026. 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.