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 include specific lot numbers from 2015-2016.
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 surgical staplers that may be missing a critical sled component. This could cause failure to properly staple tissue, leading to bleeding or leakage. Patients using these staplers should contact Medtronic for guidance.
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 patients using the Endo GIA universal or universal XL staplers with specific lot numbers from 2015-2016 are most at risk. Healthcare providers and surgical teams using these devices should check their equipment.
Check the lot numbers listed in the recall: 0214860061, 0215036240, 0215036239, 0215036238, 0215018854, 0215018855, 0215102248, 0215102247, 0215068747, 0215068748, 0215050427, 0215102246, 0215050429, 0215050428, 0215068746, 0215117409, 0215117411, 0215117410, 0215125963, 0215125962, 0215125964, 0215275313, 0215275315, 0215275314, 0215282505, 0215282506. These units were sold between 2015 and 2016.
Identify the lot numbers on your Endo GIA universal or universal XL stapler to see if they match the recalled list.
Reach out to Medtronic directly for instructions on whether your stapler needs repair or replacement.
The staplers may be missing a sled component that is necessary for proper staple deployment, which could lead to bleeding or leakage during tissue division.
Check the lot numbers listed in the recall: 0214860061, 0215036240, 0215036239, 0215036238, 0215018854, 0215018855, 0215102248, 0215102247, 0215068747, 0215068748, 0215050427, 0215102246, 0215050429, 0215050428, 0215068746, 0215117409, 0215117411, 0215117410, 0215125963, 0215125962, 0215125964, 0215275313, 0215275315, 0215275314, 0215282505, 0215282506.
No, but you should check the lot numbers and contact Medtronic for guidance on whether your stapler needs repair or replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1852-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1852-2018 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.
