Official recall notice

FDA DeviceClass IINotable

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

Recall date
2026-07-22
FDA class
Class II

Why it was recalled

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.

Product description

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.

Affected products

Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.

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