FDA Device recall Z-0821-2016
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Un…
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Un… by Medtronic, citing staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0821-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-02 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Reason
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Identifiers
| code_info | Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E04…Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X. Individual Lot Number: P5B0468X, P5E0523X, P5E0273X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0821-2016%22
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