FDA-Device2026-07-22Class IIPROCESSING DEFECT
Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
What this means
Olympus has recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because some of the sterilization instructions in the device manual may not reliably make the device sterile. The affected instructions should no longer be used.
- If you use this device, contact Olympus Corporation of the Americas for updated sterilization instructions.
- Do not use the sterilization parameters currently listed in the device manual.
- Check if your facility has Model 188 devices (all lot numbers are affected).
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
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Affected count
190 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2718-2026More Olympus recalls
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