COVIDIEN Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component
COVIDIEN MEDTRONIC is recalling 171,271 Endo GIA Universal Articulating Loading Units because a missing sled component may prevent proper staple deployment, risking bleeding or leakage during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text describes a medical device defect that can lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk. Under the rubric, defects leading to significant injury reports or high-risk functional failures in medical devices align with a Severe (4) classification.
Plain-English summary
COVIDIEN MEDTRONIC has issued a recall for the Endo GIA Auto Suture Universal Articulating Loading Unit (Item Code 030452). The affected products are single-use loading units with lot numbers N7L0191KX, N7M0944KX, N8B0234KX, and N8C0147KX. A total of 171,271 units are subject to this recall.
The recall was initiated because the device may be missing a sled component. This component is essential for staple deployment. If the sled is absent, the stapler may fail to form a complete staple line when tissue is divided. This failure can lead to bleeding or leakage of luminal contents during surgical procedures.
The affected products are distributed worldwide and throughout the United States. The manufacturer has identified this as an FDA Class II recall. Consumers and healthcare providers should check lot numbers against the provided list and contact the company for further instructions regarding these specific loading units.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) 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 (3)
- Lots: N7L0191KX
- N7M0944KX
- N8B0234KX
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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