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, triple-staggered rows. The
Check against the official notice below — it lists the full affected range.
Covidien Medtronic is recalling Endo GIA Auto Suture Universal Articulating Loading Units (30mm - 2.5mm, Item Code 030451) distributed worldwide and throughout the US. The affected devices may be missing a sled component, which is responsible for deploying staples during surgical use. Without this component, the stapler may fail to create a proper staple line when dividing tissue, potentially resulting in bleeding or leakage of internal contents.
The recall involves 171,271 units total across 12 specific lot codes. Affected consumers can identify recalled units by checking whether their device matches one of the following lot numbers: N7L0071KX, N7L0527KX, N7L0792KX, N7L0914KX, N7L1014KX, N7L1159KX, N8A0154KX, N8A0553KX, N8A0850KX, N8C0830KX, N8C0847KRX, or N8C0848KRX. The source document does not specify a remedy or action for affected consumers.
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: N7L0071KX, N7L0527KX, N7L0792KX, N7L0914KX, N7L1014KX, N7L1159KX, N8A0154KX,N8A0553KX, N8A0850KX, N8C0830KX, N8C0847KRX, N8C0848KRX GTIN # 1 (Inner Carton) - 10884523002829 GTIN # 2 (Outer Carton)- 20884523002826
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.