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Class IIOngoing

Olympus Corporation of the Americas recalls 4 products

Recall date · record updated Jul 22, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Olympus Corporation of the Americas
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98869…

Products (4)

  1. Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.

    Codes/lots: Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.Quantity: 190 unitsRecall no. Z-2718-2026Class II

  2. Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

    Codes/lots: Model Number: 188A. UDI-DI: 00821925001077. All Lot NumbersQuantity: 1,156 unitsRecall no. Z-2719-2026Class II

  3. Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

    Codes/lots: Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.Quantity: 3,241 unitsRecall no. Z-2720-2026Class II

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

    Codes/lots: Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.Quantity: 3,663 unitsRecall no. Z-2721-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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