Notice names this product. Olympus of the Americas’s Olympus Glass Body for 194 Ellik Evacuator is named in FDA Class II recall Z-2721-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Identifying details: Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.. Units affected: 3,663 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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.
Company / brand: Olympus of the Americas
Affected product: Olympus Glass Body for 194 Ellik Evacuator
Official ID Z-2721-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.