FDA Device recall Z-2142-2025
Tubing for Male Connector 194, Ellik Evacuator
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Tubing for Male Connector 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-2142-2025 |
| 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
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. 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: 190-4. UDI-DI: 00821925003491. 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-2142-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.