medical MODERATE Updated 2018-03-14

Covidien LLC recalls Endo GIA" Radial Reload with Tri-Staple" Technology The E

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Recalled Product

Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

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Hazard / Issue

The device cartridge disengaged during use due to manufacturing error.

Issued by

FDA

Distribution: Internationally, including Japan. No USA Customers
Lot/Code Info: Product number: EGIARADXT Lot code: N6L0351X

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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