FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
- Recall number
- Z-2140-2025
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
- Status
- Open, Classified
- Initiated
- 2025-06-18
- Posted
- 2025-07-21
- Terminated
- not on file
- Reason
- Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Root cause
- Packaging change control
- Action
- Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.
- Quantity
- 41 units
- Distribution
- International distribution to the country of Japan.
- Lot, serial or model codes
- Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers
- 510(k) numbers
- ["K890328"]
- PMA numbers
- not on file
- Product code
- HIH
- 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