FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc Endoscopy Division: Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
- Recall number
- Z-1105-2007
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- Product
- Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
- Status
- Terminated
- Initiated
- 2004-10-12
- Posted
- 2007-08-02
- Terminated
- 2007-08-02
- Reason
- Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
- Root cause
- Other
- Action
- Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.
- Quantity
- 274 units.
- Distribution
- Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
- Lot, serial or model codes
- Pnuematic Footswitch part of TRIVEX System with the following serial numbers: 105, 106, 108, 109, 111 -123, 125 - 182, 184 - 188, 192 - 197, 199 - 203, 205 - 219, 222 - 249, 252 - 254, and 7210386.
- 510(k) numbers
- ["K032387"]
- PMA numbers
- not on file
- Product code
- DWQ
- Firm FEI
- 1643264
- Firm city
- Oklahoma City
- Firm state
- OK
- 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