FDA Device recall Z-0003-2021
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - 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 30 mm - 3.5 mm, Item Code 030452 - 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-0003-2021 |
| 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 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.
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: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E06…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 |
|---|
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-0003-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.