Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (bleeding or leakage) from a structural defect, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Medtronic is recalling specific lots of Endo GIA universal and Endo GIA universal XL staplers. The recall involves 169,775 units distributed worldwide and in the US. The affected lots are 0214930629, 0214993038, 0215068848, 0215124286, 0215124285, 0214793818, 0215130759, and 0215243237.
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. This failure 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 should contact their healthcare provider if they have had a procedure involving these specific devices.
The recalled product
- Product
- BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) 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 d
- 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 (8)
- Lots: 0214930629
- 0214993038
- 0215068848
- 0215124286
- 0215124285
- 0214793818
- 0215130759
- 0215243237
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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