FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure
The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.
What this means for you
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, and the hazard involves a safety interlock failure in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 3,816 units of the Endo GIA Auto Suture Universal Articulating Loading Unit manufactured by Covidien LLC. The recall is classified as Class II. The affected devices are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
The recall is due to a potential failure of the device's safety interlock. This interlock is designed to prevent an empty single-use loading unit from being fired a second time. If the interlock fails, the device may fire when it should not.
The affected units were distributed nationally. The specific product codes are N7F1058KX, N7F1121KX, N7F1056KX, and N7F1057KX. Healthcare facilities and users should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
- Manufacturer
- Covidien LLC
- Affected units
- 3,816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- N7F1058KX
- N7F1121KX
- N7F1056KX
- N7F1057KX
Distribution
Distribution scope not specified by the agency.
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