Medtronic recalls Endo GIA universal and universal XL staplers that may be missing a sled component, risking bleeding or leakage during tissue division. Affected units were sold in specific lots.
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 might be missing a critical sled component. This could cause failure to properly staple tissue, leading to bleeding or leakage. Affected units were sold in specific lots.
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 bodily fluids.
Endo GIA universal and universal XL staplers used in surgical procedures. Surgeons and medical staff handling these devices are most at risk.
Check for the product name 'Endo GIA universal' or 'Endo GIA universal XL' with the specific lot numbers: 0214915642, 0214983138, 0215159225, 0215234652.
Inspect the stapler for the presence of the sled component, which is necessary for proper staple deployment.
The stapler may be missing a sled component, which is critical for forming staple lines during tissue division. This can lead to bleeding or leakage of luminal contents.
Lots 0214915642, 0214983138, 0215159225, 0215234652.
The recall does not specify a stop-use instruction; however, checking for the missing sled component is recommended to ensure safety.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1833-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1833-2018 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.
