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 prevent staple formation, 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 risk-of-harm medical device where injury (bleeding or leakage) has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit (45mm-3.5mm, Item Code 030455). The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment.
If the sled component is missing, the device may fail to form a staple line when tissue is divided during surgery. This failure could lead to bleeding or the leakage of luminal contents. The affected lots are N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0036KX, N8A0324KX, N8A0477KRX, N8A0551KX, and N8C0357KX. The GTINs are 10884523002867 (Inner Carton) and 20884523002864 (Outer Carton).
The affected products were distributed worldwide and nationwide in the US. Healthcare facilities and users should check their inventory for the specific lot numbers and GTINs listed above. If the product is found, it should be removed from use and returned to Medtronic or the distributor according to the recall instructions.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) 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, tr
- 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 (12)
- Lots: N7F0576KX
- N7L0032KX
- N7L0239KX
- N7L0519KX
- N7M0104KX
- N7M0383KX
- N7M0584KX
- N7M0696KX
- N8A0036KX
- N8A0324KX
- N8A0477KRX
- N8A0551KX
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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