Medtronic Recalls Endo GIA Ultra Universal Short Stapler Handles
Medtronic is recalling 364,768 Endo GIA Ultra Universal Short Stapler Handles because they may fail to fire or partially fire, and the articulating lever may disengage during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 that may fail to fire or have a lever disengage during use, which poses a significant risk of injury to patients during surgery.
Plain-English summary
Medtronic is recalling 364,768 units of the Endo GIA Ultra Universal 12 mm Short Stapler Handle (Ref: EGIAUSHORT). The recall covers specific lot numbers, including ranges from P3C through P5B0289X and several individual lots such as N3F0260RX and P5C0201X. The affected products were distributed worldwide, including in the United States, Canada, and numerous other countries.
The recall is being issued because the staplers may fail to fire or partially fire, and there are reports of the instrument articulating lever disengaging during use. These staplers are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis.
Healthcare providers and facilities that have received these products should stop using them immediately and contact Medtronic for instructions on how to return the affected units.
The recalled product
- Product
- Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT 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…
- Manufacturer
- Medtronic
- Affected units
- 364,768
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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