FDA Device recall Z-0004-2021
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers…
- FDA Device
- Class II
- ongoing
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers… by Covidien, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0004-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-12 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
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.
Identifiers
| code_info | Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0004-2021%22
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