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, 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. The source text explicitly states that the defect may lead to bleeding or leakage of luminal contents, which constitutes significant injury reports or risk of serious harm, meeting the criteria for a Severe (4) rating.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit (Item Code 030451). The affected units are distributed worldwide and nationwide in the US. The recall involves specific lots and GTIN numbers listed in the agency record.
The recall is being issued 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 during surgery. This failure could lead to bleeding or leakage of luminal contents.
Healthcare providers and facilities should stop using the affected loading units and contact Medtronic for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device used in surgical settings.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) 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,
- 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 (11)
- Lots: N7L0071KX
- N7L0527KX
- N7L0792KX
- N7L0914KX
- N7L1014KX
- N7L1159KX
- N8A0154KX
- N8A0553KX
- N8A0850KX
- N8C0830KX
- N8C0847KRX
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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