Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may cause staple line failure, 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 medical device where a mechanical failure could lead to bleeding or leakage of luminal contents, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit 60mm -2.5mm (Item Code 030457). The recall covers specific lots and GTINs distributed worldwide and in the US.
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.
Healthcare providers and facilities should check their inventory for the affected item codes and lot numbers listed in the recall notice. If the affected units are found, they should be removed from use and returned to Medtronic according to the instructions provided.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) 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 (9)
- Lots: N7D0492KRX
- N7F0518KX
- N7F0651KX
- N7L0270KX
- N7L0699KX
- N7L0732KX
- N7L1043KX
- N8A0213KX
- N8B0002KX
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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- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
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