Lower riskMedical device recall · FDA · Published April 15, 2026
Covidien EndoStitch Polysorb Loading Unit Recall: Sterile Package Risk
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.
Take action
Contact the company
📍Recalling firmCovidien, LP60 Middletown Ave · North Haven, CT 06473-3908
“Covidien EndoStitch Polysorb Loading Unit Recall: Sterile Package Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49463-covidien-endostitch-polysorb-loading-unit-recall-sterile-package-risk. Based on FDA recall #Z-2281-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2281-2026%22&limit=1).
The FDA announced on April 15, 2026, that Covidien, LP is recalling its EndoStitch Polysorb Single Use Loading Units due to holes in the pouch that compromise sterility. Owners should stop using the affected devices immediately.
How to tell if you have it
Brand: Covidien
Product: EndoStitch Polysorb Single Use Loading Unit
Product numbers: 170053 and 170071
Lot number J5L2332Y (Product Number 170053)
Lot number J5H2924Y (Product Number 170071)
The hazard
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, according to the FDA.
Context
GovInfoNow's records show Covidien, LP has 26 other recalls on record since July 17, 2017. Other recent recalls of similar products include Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026), Covidien Signia Small Diameter Curved Tip Recall (Sept. 25, 2025), and Covidien Chameleon PTA Balloon Catheter Recall (Sept. 19, 2024). Other recent recalls of similar products include Medline Convenience Kits Recall (June 12, 2026), Medline IVS Blood Culture Kits Recall (June 12, 2026), and Medline C-Section Prep Kits Recall (June 12, 2026).
How to tell if you have this one
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.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Number
Look for product numbers 170053 or 170071 on the packaging to confirm if the unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2281-2026 (April 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2281-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.