FDA recall Z-2721-2026

Product

Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

Reason for recall

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

Key facts

Status

Ongoing

Initiation date

2026-05-05

Report date

2026-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2721-2026