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. If you own one of these devices, stop using it immediately.
The sled component is essential for properly deploying staples when dividing tissue. If missing, the stapler may fail to create a secure staple line, causing tissue to bleed or leak luminal contents during surgery.
Surgical teams and medical professionals who use the Endo GIA universal or universal XL staplers for gastrointestinal procedures are most at risk. Patients undergoing surgery with these devices could experience bleeding or leakage.
Check for the model number 'BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII' on the device. Affected units were sold with lot number 0214726876.
Immediately stop using the Endo GIA universal or universal XL staplers if they have the model number 'BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII' and lot number 0214726876.
The model number is 'BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII'.
The staplers may be missing a critical sled component, which can cause failure to form staple lines during tissue division, leading to bleeding or leakage.
Check for the model number 'BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII' and lot number 0214726876 on the device.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1862-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1862-2018 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.