Olympus Corporation Of The Americas: Evacuator, Gastro-urology
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/80cce84f-704a-4b2d-8319-ca9ff86b3311