Medtronic recalls Endo GIA universal and universal XL staplers that may have a missing sled component, causing failure to form staple lines and potential 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 that may be missing a critical sled component. 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 staplers may fail to form a staple line when dividing tissue, which can lead to bleeding or leakage of luminal contents during surgery.
Surgical staff using Medtronic Endo GIA universal or universal XL staplers for tissue division procedures are most at risk. Patients undergoing surgery with these devices may experience bleeding or leakage if the sled component is missing.
Check for the lot numbers 0215017845, 0215002541, or 0215104507 on the packaging or device. These specific models are affected by the recall.
Inspect the stapler for a missing sled component, which is critical for staple deployment.
The Endo GIA universal and Endo GIA universal XL staplers with lot numbers 0215017845, 0215002541, or 0215104507 are affected.
The staplers may be missing a sled component, which is necessary for forming staple lines during tissue division, potentially causing bleeding or leakage.
Check if your stapler has the specific lot numbers listed. If it does, inspect for a missing sled component and contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1850-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1850-2018 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.
