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, triple-staggered rows. The s
Check against the official notice below — it lists the full affected range.
Covidien Medtronic has recalled the Endo GIA Auto Suture Universal Articulating Loading Unit 60mm-2.5mm (Item Code 030457) because certain units may be missing a sled component, which is the part responsible for deploying staples. Without this component, the device may fail to form a proper staple line when tissue is divided during surgery, potentially causing bleeding or leakage of internal contents. This recall affects approximately 171,271 units distributed worldwide and throughout the United States across ten specific lot codes.
The source document does not specify a remedy or any instructions for affected consumers regarding what action they should take.
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: N7D0492KRX, N7F0518KX, N7F0651KX, N7L0270KX, N7L0699KX, N7L0732KX, N7L1043KX, N8A0213KX, N8B0002KX, N8C0429KX GTIN # 1 (Inner Carton) - 10884523002881 GTIN # 2 (Outer Carton)- 20884523002888
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.