FDA Device recall Z-2141-2025
Glass Body For 194 Ellik Evacuator
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Glass Body For 194 Ellik Evacuator by Olympus, citing discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2141-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-18 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | n/a |
Product
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Identifiers
| code_info | Model Number: 190A. UDI-DI: 00821925003538. All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2025%22
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