Medtronic recalls Endo GIA universal and universal XL staplers that may have a missing sled component, risking bleeding or leakage during tissue division. Affected units were sold with specific lot numbers.
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 cause failure to form staple lines when dividing tissue, leading to bleeding or leakage.
The sled component is essential for deploying staples correctly. If missing, the stapler may fail to form a staple line when dividing tissue, causing bleeding or leakage of internal fluids.
Surgical professionals using Medtronic Endo GIA staplers for procedures involving tissue division. Those with the specific lot number 0215244887 are most at risk.
Check for the lot number 0215244887 on the product packaging. The affected staplers are Endo GIA universal and universal XL models used in surgical procedures.
Look for the lot number 0215244887 on the packaging or label of the stapler.
The Endo GIA universal and Endo GIA universal XL staplers.
The staplers may be missing a sled component, which can cause failure to form staple lines when dividing tissue, leading to bleeding or leakage.
Check for the lot number 0215244887 on the packaging or label.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1858-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1858-2018 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.