FDA-Device2020-10-07Class IIPROCESSING DEFECT
Covidien Endo GIA Auto Suture stapler recalled for incomplete staple formation
OTHERNationwide distribution
Check Endo GIA stapler lot numbers immediately
Covidien has recalled certain Endo GIA Auto Suture Universal Articulating Loading Units used in surgery because the staples may not form properly when applied. Incomplete staple formation could prevent adequate sealing of blood vessels during surgery. This affects specific lot numbers manufactured between certain dates.
- If you have this device in your facility, check the lot number against the FDA recall list
- Do not use affected units in surgery
- Contact Covidien immediately for instructions on replacement or return
- Notify your surgical team and hospital supply chain of the recall
Hazard
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Sold states
Worldwide distribution - US Nationwide and Global Distribution.
Affected count
900,007 total
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2021Don't want to check this manually?
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