Olympus recalls Toomey Evacuator 30cc with Adaptor (Model 188) due to potential failure in sterilization. Affected units may not render devices adequately sterile, risking infection.
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.
Olympus is recalling its Toomey Evacuator 30cc with Adaptor (Model 188) because some sterilization settings in the instructions might not properly sterilize medical devices. This could lead to infections if used incorrectly.
The device's sterilization settings in the instructions might not consistently ensure medical devices are sterile. This could lead to infections if the device is used without proper sterilization.
Healthcare professionals using this device for sterilization may be affected. Patients or staff using improperly sterilized devices could face infection risks.
Check for the model number 188 on the device. The product was sold with UDI-DI: 00821925001053 and all lot numbers.
Review the device's instructions for sterilization parameters to ensure they are followed correctly.
The device may not render devices adequately sterile if sterilization parameters are not followed correctly, so it should not be used without proper sterilization.
The official recall does not specify a remedy, so check the device's instructions for sterilization parameters and ensure they are followed correctly.
Look for the model number 188 on the device. The product was sold with UDI-DI: 00821925001053 and all lot numbers.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2718-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2718-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
