Smith & Nephew TRIVEX System Pneumatic Footswitch, Part… recallZ-1105-2007 · Smith & Nephew, Inc Endoscopy Division · initiated Oct 12, 2004
Terminated All recalls posted in August 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc Endoscopy Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1105-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 12, 2004
- Posted by the FDA
- Aug 2, 2007
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- Quantity
- 274 units.
- Product code
- DWQ
- FDA submissions
- K032387
- Distribution
- Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
Product description
Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
3 devices cleared under K032387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trivex System 7210387Lemaitre Vascular, Inc. · Stripper, Vein, External60 reports
- Trivex System 7210387FLemaitre Vascular, Inc. · Stripper, Vein, External6 reports
- Trivex System 7210386Lemaitre Vascular, Inc. · Stripper, Vein, External3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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