FDA-Device2026-07-22Class IIPROCESSING DEFECT
Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
What this means
Olympus has recalled the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization instructions in the product manual may not reliably make the device fully sterile. Affected units were distributed worldwide, including across the US, Canada, Japan, Europe, and Latin America.
- If you have Model 188A (UDI-DI: 00821925001077), do not use the sterilization parameters listed in the instructions.
- Contact Olympus Corporation of the Americas for corrected sterilization guidance or device replacement.
- Review any procedures that may have used this device with the old sterilization method.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Affected count
1,156 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2719-2026More Olympus recalls
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- FDA-Device2026-10-07Olympus M3 Gold Autoclavable Foroblique Telescope recalled for sterilization parameter discrepancies
- FDA-Device2026-09-30Olympus BiCOAG Hemostasis Probe recalled for ceramic tip detachment risk
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