Medtronic Recalls Endo GIA Ultra Universal Stapler Handles Due to Firing Defects
Medtronic is recalling 1,102,166 Endo GIA Ultra Universal Standard Stapler Handles worldwide because they may fail to fire or partially fire 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 defect (failure to fire or lever disengagement) that poses a significant risk of injury during surgery, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling 1,102,166 units of the Endo GIA Ultra Universal Standard Stapler Handle (Ref: EGIAUSTND) due to reports that the staplers fail to fire or partially fire. The recall also covers reports of the instrument articulating lever disengaging during use. These staplers are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
The affected products were distributed worldwide, including in the United States, Canada, and numerous other countries. The recall includes specific ranges of lot numbers starting with P3C through P5B0521X, P5D0410X through P5D0411X, P5D0823X through P5D0829X, P5E0080X through P5E0082X, P5E0317X through P5E0320X, P5E0322X through P5E0324X, and P5F0001X through P5F0002X, as well as a list of individual lot numbers provided in the official notice.
Healthcare facilities and users should stop using the affected stapler handles and contact Medtronic for instructions on how to return the devices. The source text does not specify a particular date for the recall initiation or specific instructions for end consumers, as these are medical devices intended for professional use.
The recalled product
- Product
- Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND 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 resec
- Manufacturer
- Medtronic
- Affected units
- 1,102,166
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 (20)
- P5C0241X
- P5C0508X
- P5C0510X
- P5C0512X
- P5C0597X P5C0599X
- P5C0601X
- P5C0603X
- P5C0684X
- P5C0803X
- P5C0805X
- P5C0807X. P5E0527X
- P5E0529X P5D0067X
- P5D0069X
- P5D0073X
- P5D0170X
- P5D0413X
- P5D0415X
- P5D0417X
- P5D0419X
- P5D0447X
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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