Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Universal staplers because a missing sled component 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 that can lead to significant injury (bleeding or leakage of luminal contents) during surgery.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Universal and Endo GIA Universal XL staplers (Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S). The recall affects Lot 0215227169, which was distributed worldwide and across the United States.
The recall was initiated because 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 can lead to bleeding or the leakage of luminal contents during surgical procedures.
Healthcare providers and facilities should stop using the affected devices immediately. Consumers are not directly affected as these are surgical instruments used by medical professionals. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) 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-sta
- 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 (1)
- Lot 0215227169
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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