Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling 169,775 Endo GIA universal staplers worldwide and in the US because a missing sled component may prevent staple formation, leading to bleeding or leakage.
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 risk of significant injury (bleeding or leakage of luminal contents), which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Medtronic is recalling 169,775 units of Endo GIA universal and Endo GIA universal XL staplers. The recall covers devices distributed worldwide and in the US, specifically lots 0215017845, 0215002541, and 0215104507.
The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment. If the sled is missing, the device may fail to form a staple line when tissue is divided, which could lead to bleeding or leakage of luminal contents.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices. Consumers are not expected to have these professional medical devices in their homes.
The recalled product
- Product
- MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the sele
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 169,775
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 (3)
- Lot: 0215017845
- 0215002541
- 0215104507
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by COVIDIEN 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.
See all 40 products in this recall →Related recalls
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