Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to 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 involves a high-risk medical device where a mechanical failure could lead to bleeding or leakage, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic is recalling 169,775 units of Endo GIA Universal and Endo GIA Universal XL staplers. The recall is due to a potential missing sled component, which is responsible for staple deployment.
The missing component may result in the failure to form a staple line when tissue is divided. This failure could lead to bleeding or the leakage of luminal contents. The affected lots are 0215050309, 0215108007, 0215050310, 0215050308, 0215050311, 0215050312, 0215050313, 0215037144, 0215037143, and 0215108008.
The products were distributed worldwide and nationwide in the US. Healthcare providers should stop using the affected devices and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- BOX PST03699 KIT APP MED ALTERNATIV STAP 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 de
- 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 (10)
- Lots: 0215050309
- 0215108007
- 0215050310
- 0215050308
- 0215050311
- 0215050312
- 0215050313
- 0215037144
- 0215037143
- 0215108008
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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