Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-07-22
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Firm state
PA
Product quantity
3,241 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason 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.
Product description
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Code / lot info
Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.