Olympus Toomey Evacuator 30cc with Adaptor — Class II medical device recall Z-2718-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-07-22, distributed nationwide. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile a
| Recall number | Z-2718-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2026-05-05 |
| Classified | 2026-07-10 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 190 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00821925001053 |
| Model numbers | 188 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2718-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.