FDAFDA recall Z-2718-2026 · Jul 22, 2026
Olympus Corporation of the Americas: Olympus Toomey Evacuator 30cc with Adaptor recall
Recall found
Product
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.
- Quantity
- 190 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-05
Source: openFDA enforcement record Z-2718-2026 · search recall number Z-2718-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.