Medtronic Recalls Endo GIA Ultra Universal Stapler Handles in Best Practice Kits
Medtronic is recalling 2,711 Best Practice Kits containing specific Endo GIA Ultra Universal Stapler Handles due to reports of staplers failing to fire or partially firing, and articulating levers disengaging during use.
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 use, which poses a significant risk of injury or property damage in a medical setting.
Plain-English summary
Medtronic is recalling 2,711 Best Practice Kits that contain certain production lots of Endo GIA Ultra Universal Stapler Handles. These staplers are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis. The recall covers kits distributed worldwide, including the United States, Canada, and numerous other countries.
The recall is being conducted because of reports that the staplers fail to fire or partially fire, and that the instrument articulating lever disengages during use. The affected kits are identified by specific lot numbers, including 00B0203, 00Z1924, 00Z1992, and others listed in the official recall documentation.
Healthcare facilities and users should check their inventory for the affected lot numbers and stop using these specific stapler handles. Medtronic is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles 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 th
- Manufacturer
- Medtronic
- Affected units
- 2,711
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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