FDA Device recall Z-0008-2021
Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - 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 60 mm - 3.5 mm, Item Code 030458 - 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-0008-2021 |
| 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 60 mm - 3.5 mm, Item Code 030458 - 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: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085…Lot Numbers: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X T8M011X T9G089X T0B047X T8A002X T8E068X T8M097X T9G090X T0B056X T8A003X T8F001X T9A009X T9G094X T0B073X T8A004X T8F002X T9A031X T9G159X T0B081X T8A045X T8F026X T9A056X T9G160X T0C043X T8A046X T8F045X T9A099X T9H042X T0C068X T8A060X T8F046X T9B001X T9H100X T0C069X T8A061X T8F047X T9B004X T9H101X T0C070X T8B003X T8F077X T9B005X T9H113X T0C103X T8B037X T8H001X T9B038X T9H114X T0D054X T8B038X T8H002X T9C007X T9J030X T0D059X T8B039X T8H003X T9C008X T9J035X T0D061X T8B040X T8H005X T9C069X T9J048X T0D115X T8B041X T8H006X T9C070X T9J073X T0E050X T8C012X T8H019X T9C071X T9J096X T7F01 |
|---|
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-0008-2021%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.