Medtronic recalls Endo GIA Universal Articulating Loading Units 60mm-2.5mm (Item 030457) due to potential missing sled component causing staple deployment failure, leading to bleeding or leakage during tissue division.
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 60mm-2.5mm (Item Code 030457) because the device may be missing a critical sled component that can cause staple deployment failure. This could lead to bleeding or leakage of tissue contents during surgical procedures.
The device may be missing a sled component that is essential for staple deployment. Without this component, the device might fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of internal body contents.
Surgical professionals using the Endo GIA Universal Articulating Loading Units 60mm-2.5mm (Item Code 030457) are most at risk, particularly those operating on patients where tissue division is required.
Check for the Endo GIA Universal Articulating Loading Unit 60mm-2.5mm (Item Code 030457) with lot numbers N7D0492KRX, N7F0518KX, N7F0651KX, N7L0270KX, N7L0699KX, N7L0732KX, N7L1043KX, N8A0213KX, N8B0002KX, or N8C0429KX.
Verify the lot number on the device packaging to see if it matches the listed lots: N7D0492KRX, N7F0518KX, N7F0651KX, N7L0270KX, N7L0699KX, N7L0732KX, N7L1043KX, N8A0213KX, N8B0002KX, or N8C0429KX.
Reach out to Medtronic directly for further assistance or to confirm if your device is affected.
The recalled device is the Endo GIA Universal Articulating Loading Unit 60mm-2.5mm (Item Code 030457).
The device may be missing a critical sled component that can cause staple deployment failure, potentially leading to bleeding or leakage of tissue contents during surgery.
Check the lot number on the device packaging; affected units have lot numbers N7D0492KRX, N7F0518KX, N7F0651KX, N7L0270KX, N7L0699KX, N7L0732KX, N7L1043KX, N8A0213KX, N8B0002KX, or N8C0429KX.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1819-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1819-2018 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.
