Olympus Toomey Evacuator 50cc with Adaptor: recall status
Notice names this product. Olympus of the Americas’s Olympus Toomey Evacuator 50cc with Adaptor is named in FDA Class II recall Z-2719-2026.
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: 188A. UDI-DI: 00821925001077. All Lot Numbers. Units affected: 1,156 units. Status: Ongoing.
1. Compare your item
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.
Product named
Olympus Toomey Evacuator 50cc with Adaptor
Company / brand
Olympus of the Americas
Lot / serial / date codes
Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Agency product description and boundaries
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
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.