FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Recall number
- Z-2719-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Status
- Open, Classified
- Initiated
- 2026-05-05
- Posted
- 2026-07-10
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- Olympus notified consignees on about 06/05/2026 via Courier, 2-day delivery. Consignees were requested to examine inventory for affected units. If affected units are on hand, replace any existing sterilization instructions for these products with those provided with the notification and add these instructions to any existing copies of the IFU. Consignees were also instructed to acknowledge receipt of the customer letter through the web portal. If affected units were further distributed, Olympus instructed consignees to identify those customers and forward the notification to them. An updated notice was sent to consignees on 06/30/2026 with further clarification regarding instructions to be used to sterilize affected devices going forward.
- Quantity
- 1,156 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- Lot, serial or model codes
- Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQT
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28