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Olympus Corporation of the Americas: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

Medical DevicesSource: FDA (device) · Date: 2026-07-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Recall initiated
2026-05-05
Code info
Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
Product quantity
3,663 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98869
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