Medtronic Endo GIA Stapler Sleeves Recalled for Missing Sled Component
Medtronic is recalling 169,775 Endo GIA stapler sleeves worldwide due to a missing sled component that may prevent staple formation, risking 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 in a surgical device 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 stapler sleeves, including specific lot numbers for Box Sleeve GK3, GK4, JAWI, and ZEST DO products. The recall covers distribution in the United States and worldwide.
The recall is issued because the device may be missing a sled component, which is responsible for staple deployment. If the sled 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 facilities and distributors should stop using the affected products and contact Medtronic for instructions on return or replacement. The specific lot numbers affected are 0215050387, 0215193250, 0214933111, 0214030210, 0215041719, 0215161529, 0215272924, 0214985253, 0215104506, and 0215298203.
The recalled product
- Product
- (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of t
- 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 (7)
- Lot Numbers: (1) 0215050387
- 0215193250 (2) 0214933111 (3) 0214030210
- 0215041719
- 0215161529
- 0215272924 (4) 0214985253
- 0215104506
- 0215298203
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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