FDA recall Z-2145-2025

Olympus Corporation of the Americas · Class II · device

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).

Distribution

International distribution to the country of Japan.

Key facts

Status
Ongoing
Initiation date
2025-06-18
Report date
2025-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2145-2025