Signia Power Handle Recalled for Shutting Down During Surgical Use
Covidien LLC is recalling 2,121 Signia Power Handles because they reportedly shut down during use. The devices are used in various surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a surgical device shutting down during use, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Covidien LLC is recalling 2,121 units of the Signia Power Handle (SIGPHANDLE, SIGNVAL1 and SIGNVAL20 - Kits). The recall was initiated because the product was reportedly shutting down during use.
The Signia Power Handle is used with Endo GIA single-use reloads and Endo GIA single-use reloads with Tri-Staple Technology. It has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
The affected units were distributed worldwide, including nationwide in the United States. Users should check their serial numbers against the list provided in the official recall notice and stop using the device if it is affected.
The recalled product
- Product
- Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal…
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 2,121
Distribution
Distributed nationwide across the United States.
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