Medtronic recalls Endo GIA universal staplers with specific lot numbers due to a missing sled component that could cause 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 and universal XL staplers with certain lot numbers because a critical sled component may be missing. This could lead to failure in forming staple lines when dividing tissue, potentially causing bleeding or leakage.
The sled component is essential for proper staple deployment. If missing, the stapler may fail to create a secure staple line when dividing tissue, which can result in bleeding or leakage of bodily fluids.
Users of Endo GIA universal and universal XL staplers with specific lot numbers are affected. Surgeons and medical professionals who use these devices during procedures are at the highest risk.
Check the lot numbers listed in the recall notice: 0214014173, 0214573291, 0214621781, 0214909631, 0215068744, 0215068743, 0215108744, 0215108743, 0215276369, 0214798114, 0214618312, 0214795633, 0215002022, 0215010930, 0215010931, 0215010932, 0215132611, 0215132612, 0215132613, 0215264173.
Identify the lot number on your Endo GIA universal or universal XL stapler. If it matches the listed numbers, it is affected.
Reach out to Medtronic for guidance on next steps, as the recall remedy is not specified in the record.
The stapler may be missing a critical sled component that is necessary for staple deployment. This could lead to failure in forming staple lines when dividing tissue, potentially causing bleeding or leakage.
Lot numbers 0214014173, 0214573291, 0214621781, 0214909631, 0215068744, 0215068743, 0215108744, 0215108743, 0215276369, 0214798114, 0214618312, 0214795633, 0215002022, 0215010930, 0215010931, 0215010932, 0215132611, 0215132612, 0215132613, 0215264173.
The recall record does not specify a remedy, so contact Medtronic directly for instructions on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1842-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1842-2018 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.
