Skip to content
Recall Observatory FDA recall evidence

Device product

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0003-2021

August 12, 2020

Class II

Product summary

Firm
Covidien, LP
Event
Event 86214
Status
Ongoing
Classification
Class II
Quantity
900,007 total
Official record key
device-enforcement:Z-0003-2021

Official wording

Reason: 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.

Code information: Lot Numbers: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X

Distribution pattern: Worldwide distribution - US Nationwide and Global Distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly error