Olympus Corporation of the Americas: Medical Device Recall in 2025 - (Recall #: Z-2144-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

Product Classification:

Class II

Date Initiated: June 18, 2025

Date Posted: July 30, 2025

Recall Number: Z-2144-2025

Event ID: 96982

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).

Status: Ongoing

Product Quantity: 48 units

Code Information:

Model Number: 194-2. UDI: 00821925002593. All lot numbers

Distribution Pattern:

International distribution to the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated