Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units 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. The hazard involves a structural defect in a surgical device that can lead to significant injury (bleeding or leakage of luminal contents) during a procedure, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit (30mm-2.0mm, Item Code 030450). The affected lots are N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, and N8C1303KRX. The product was distributed worldwide and in the US nationwide.
The recall was initiated because the device may be missing a sled component, which 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 leakage of luminal contents during surgical procedures.
Healthcare providers and facilities should check their inventory for the specific item code and lot numbers listed above. If the affected units are found, they should be removed from service and returned to Medtronic according to the recall instructions.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) 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, t
- 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 (4)
- Lots: N7L0306KX
- N7M0221KX
- N8B0724KX
- N8C0958KX
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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