Medtronic Recalls Endo GIA Ultra Universal 12 mm XL Stapler Handles
Medtronic is recalling 327,797 Endo GIA Ultra Universal 12 mm XL Stapler Handles worldwide because the staplers may fail to fire or the articulating lever may disengage during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a surgical instrument failure (stapler not firing or lever disengaging) during active surgery, which poses a significant risk of injury to patients.
Plain-English summary
Medtronic is recalling 327,797 units of the Endo GIA Ultra Universal 12 mm XL Stapler Handle (Ref: EGIAUXL) due to reports of the staplers failing to fire or partially firing, and the instrument articulating lever disengaging during use. The affected products are distributed worldwide, including in the United States and numerous international markets.
The recalled stapler handles are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis. They may also be used for transection and resection of liver substance, hepatic vasculature, and biliary structures, or to blunt dissect or separate target tissue when used with specific single-use reloads.
The recall covers specific lot numbers, including ranges starting with P3C through P5B0454X and P5C0152X through P5E0450X, as well as individual lots P5B0468X, P5E0523X, and P5E0273X. Healthcare providers and facilities should check their inventory against these lot numbers and stop using the affected devices.
The recalled product
- 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 resecti
- Manufacturer
- Medtronic
- Affected units
- 327,797
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- P5B0468X
- P5C0152X through P5E0450X. Individual Lot Number: P5B0468X
- P5E0523X
- P5E0273X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Medtronic under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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