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
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 the source text explicitly states that the defect may lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk.
Plain-English summary
Medtronic is recalling specific boxes of Endo GIA Universal and Endo GIA Universal XL staplers. The affected products include the KITDE0143 BYPASS BOX and the KITDE0154 BYPASS KH NORDWEST box. A total of 171,271 units were distributed worldwide and in the US nationwide.
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 during surgery. This failure could lead to bleeding or the leakage of luminal contents.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices. The specific lot numbers for the KITDE0143 BYPASS BOX are 0214463634 and 0215280952. The specific lot numbers for the KITDE0154 BYPASS KH NORDWEST box are 0214013887, 0214144177, 0214260194, 0214470767, 0214956044, 0214620382, 0214744957, 0215079103, and 0215151206.
The recalled product
- Product
- (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, tri
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 171,271
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 (9)
- Lot Numbers: (1) 0214463634
- 0215280952 (2) 0214013887
- 0214144177
- 0214260194
- 0214470767
- 0214956044 0214620382
- 0214744957
- 0215079103
- 0215151206
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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