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, triple-staggered rows. The
Check against the official notice below — it lists the full affected range.
Covidien Medtronic is recalling the Endo GIA Auto Suture Universal Articulating Loading Unit 30mm - 3.5mm (Item Code 030452) because the device may be missing a sled component responsible for staple deployment. Without this component, the stapler may fail to form a proper staple line when tissue is divided, potentially resulting in bleeding or leakage of luminal contents. The recall affects 171,271 units distributed worldwide and throughout the United States, with affected lot codes N7L0191KX, N7M0944KX, N8B0234KX, and N8C0147KX.
The recall record does not specify what action affected consumers or healthcare facilities should take regarding the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Reason for recall: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. Distribution: Worldwide and US Nationwide Quantity: 171,271 units in total Lot/code info: Lots: N7L0191KX, N7M0944KX, N8B0234KX,N8C0147KX GTIN # 1 (Inner Carton) - 10884523002836 GTIN # 2 (Outer Carton)- 20884523002833
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.