Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, potentially causing 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 structural defect that can lead to significant injury, specifically bleeding or leakage of luminal contents.
Plain-English summary
Medtronic is recalling 169,775 units of Endo GIA universal and Endo GIA universal XL staplers. The affected products are identified by lot numbers 0215122341 and 0215226207 and were distributed worldwide and in the US.
The recall was initiated because the device may be missing a sled component, which is responsible for staple deployment. If the component is missing, the stapler may fail to form a staple line when tissue is divided. This failure can lead to bleeding or leakage of luminal contents during surgical procedures.
Healthcare providers and facilities should stop using the affected units and contact Medtronic for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BOX VMIN ZESTAW DO VATS PODSTAWOWY 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 determin
- 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 (2)
- Lots: 0215122341
- 0215226207
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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