Covidien recalls EndoStitch Polysorb Single Use Loading Units with product numbers 170053 and 170071 due to potential pouch holes compromising sterility. Affected units may not protect the product from environmental exposure.
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Covidien is recalling two specific models of EndoStitch Polysorb Single Use Loading Units because holes in the pouch could break the sterile seal. This risk means the product might be exposed to contaminants, which could lead to infections during medical procedures.
Holes in the pouch might allow contaminants to enter the sterile packaging, potentially leading to infections during medical procedures. The product is designed for single-use in surgeries, so any breach in sterility could cause serious complications.
Medical professionals using these units during surgeries or procedures are most at risk. Patients receiving the product could be affected if the sterility is compromised.
Check for product numbers 170053 or 170071 on the packaging. The units were sold with specific lot numbers: J5L2332Y for 170053 and J5H2924Y for 170071.
Look for product numbers 170053 or 170071 on the packaging to confirm if the unit is affected.
The presence of holes in the pouch may compromise the package's ability to maintain sterility and protect the product from environmental exposure.
Check the product number and lot number on the packaging. If it matches the recalled units (170053 or 170071), contact Covidien for instructions.
The recall is due to potential contamination risks during medical procedures, not direct injury to users.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2281-2026 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2281-2026 from Covidien. 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.
