Medtronic recalls Endo GIA Universal Articulating Loading Units 45mm-2.5mm (Item 030454) due to potential missing sled component causing staple deployment failure, leading to bleeding or leakage.
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.
Medtronic is recalling Endo GIA Universal Articulating Loading Units 45mm-2.5mm (Item Code 030454) because a missing sled component may cause staple deployment failure during tissue division, potentially leading to bleeding or leakage.
The sled component is critical for staple deployment. If missing, the device may fail to form a staple line when dividing tissue, causing bleeding or leakage of bodily fluids.
Patients using the Endo GIA universal staplers with the recalled loading units are at risk. Surgeons and medical staff who use these devices during procedures are most vulnerable.
Check for the Endo GIA Universal Articulating Loading Unit 45mm-2.5mm (Item Code 030454) with lot numbers N7K1146KX through N8C0630KX. The product is sold in cartons with GTINs 10884523002850 and 20884523002857.
Inspect the loading unit for a missing sled component, which may cause staple deployment failure.
The recalled product is the Endo GIA Universal Articulating Loading Unit 45mm-2.5mm (Item Code 030454).
If the sled component is missing, the device may fail to form a staple line when dividing tissue, leading to bleeding or leakage of luminal contents.
Lot numbers N7K1146KX, N7L0355KX, N7L1119KX, N7M0088KX, N7M0343KX, N7M0477KRX, N7M0509KX, N7M0520KX, N7M0521KX, N8A0312KRX, N8A0360KX, N8A0433KX, N8A0434KX, N8A0435KX, N8B0487KX, N8C0026KX, N8C0119KX, N8C0630KX.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1817-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1817-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
