FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
- Recall number
- Z-0424-2023
- Recalling firm
- Olympus Corporation of the Americas
- Product
- HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
- Status
- Open, Classified
- Initiated
- 2022-11-04
- Posted
- 2022-12-07
- Terminated
- not on file
- Reason
- An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.
- Root cause
- Packaging process control
- Action
- On November 4, 2022, the firm notified affected customers. Customers were instructed to identify any affected product in their inventory. Affected product should be returned to Olympus, who will issue a credit to the customer upon return of affected product. Those who have distributed the devices outside their facility should notify their customers of this removal action immediately. To return product, contact your Olympus customer service representative at 1-800-848-9024.
- Quantity
- 186 boxes (930 pieces)
- Distribution
- US Nationwide domestic distribution.
- Lot, serial or model codes
- Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202
- 510(k) numbers
- ["K171965"]
- PMA numbers
- not on file
- Product code
- FJL
- 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