Medtronic recalls Endo GIA universal staplers with missing sled components that could cause bleeding or leakage during tissue division. Affected units have specific item codes and 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 staplers that may have a missing sled component. This could lead to failure in forming staple lines when dividing tissue, causing bleeding or leakage. Affected units have specific item codes and lot numbers.
The sled component is critical for deploying staples properly. If missing, the stapler may not form a staple line when dividing tissue, which can cause bleeding or leakage of bodily fluids.
Medical professionals using Endo GIA universal staplers for surgical procedures are most at risk. Patients undergoing surgery with these devices could experience bleeding or leakage if the staple line fails.
Check for item codes: 01KBAR006116V PROC BYPASS or BOX1073076GASB0 BBR STVEIT GASTRIC B. Affected units have specific lot numbers: 0214710711, 0214043771, 0214232317, 0214375093, 0215113531, 0215132607.
Look for item codes 01KBAR006116V PROC BYPASS or BOX1073076GASB0 BBR STVEIT GASTRIC B on the device packaging.
The sled component may be missing, which can cause failure to form a staple line when dividing tissue, leading to bleeding or leakage.
Check for item codes 01KBAR006116V PROC BYPASS or BOX1073076GASB0 BBR STVEIT GASTRIC B and lot numbers 0214710711, 0214043771, 0214232317, 0214375093, 0215113531, or 0215132607.
The recall does not specify a stop-use instruction, so you can continue using it but should check for the missing component if you suspect issues.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1826-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1826-2018 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.
