FDA recall, , Moderate risk
Olympus Evacuators
Some sterilization parameters may not consistently render the devices adequately sterile.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, of Center Valley, Pennsylvania, began a recall on May 5, 2026, for several evacuator devices, including the Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb, the Olympus Toomey Evacuator 30cc with Adaptor, the Olympus Glass Body for 194 Ellik Evacuator, and the Olympus Toomey Evacuator 50cc with Adaptor.
The FDA added the recall to its Enforcement Report and classified it on July 10, 2026, with the weekly enforcement report on July 22, 2026. The reason stated by the agency is that 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.
The devices were distributed worldwide, including US Nationwide and the countries of Canada, Japan, EU, and Latin America.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus Toomey Evacuator 30cc with Adaptor.
- Model
- 188
- UDI-DI
- 00821925001053
- Lot code
- All Lot Numbers
Olympus Toomey Evacuator 50cc with Adaptor.
- Model
- 188A
- UDI-DI
- 00821925001077
- Lot code
- All Lot Numbers
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb.
- Model
- 194
- UDI-DI
- 0082192500586
- Lot code
- All Lot Numbers
Olympus Glass Body for 194 Ellik Evacuator.
- Model
- 190A
- UDI-DI
- 00821925003538
- Model code
- 190A.
- Lot code
- All Lot Numbers
Some entries omit identifying details. Check the notice to confirm which units are affected.
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98869
- Recall numbers
- Z-2718-2026 to Z-2721-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
