Medtronic recalls Endo GIA Auto Suture Universal Articulating Loading Units 60mm-3.5mm (Item 030458) 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 Auto Suture Universal Articulating Loading Units 60mm-3.5mm (Item Code 030458) because the device may be missing a critical sled component needed for staple deployment. This could cause failure to form a staple line when dividing tissue, resulting in bleeding or leakage of luminal contents during surgery.
The recalled loading units may be missing a sled component that is essential for properly deploying staples. Without this component, the device cannot form a staple line when tissue is divided, which can lead to bleeding or leakage of bodily fluids from the surgical site.
Surgical professionals using the Endo GIA universal staplers with the recalled loading units (60mm-3.5mm) are most at risk. Patients undergoing procedures requiring tissue division with these devices could experience bleeding or leakage.
Check for the Endo GIA Auto Suture Universal Articulating Loading Unit 60mm-3.5mm (Item Code 030458). The product was sold with specific lot numbers listed in the recall notice. The GTIN numbers are 10884523002898 (inner carton) and 20884523002895 (outer carton).
Inspect the loading unit for the presence of the sled component, which is critical for staple deployment.
If the sled component is missing, contact Medtronic directly for a replacement unit or repair instructions.
The recalled device is the Endo GIA Auto Suture Universal Articulating Loading Unit 60mm-3.5mm (Item Code 030458).
Failure to form a staple line when dividing tissue could lead to bleeding or leakage of luminal contents.
Check for the specific lot numbers listed in the recall notice (N7L0911KX, N7M0067KX, etc.) or the GTIN numbers 10884523002898 (inner carton) and 20884523002895 (outer carton).
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1820-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1820-2018 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.
