Ellik Evacuator Adapter — Class II medical device recall Z-2145-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-07-30. Discrepancies between sterilization instructions in the Japanese language product package inserts and those pu
| Recall number | Z-2145-2025 |
|---|---|
| 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 | 2025-06-18 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| Countries outside the US | JP |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00821925003521 |
| Model numbers | 190-NRS |
Product
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason for recall
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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-2145-2025. 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.