{"url_path":"/fda/device/recalls/Z-2281-2026","section_key":"summary","section_title":"DEVICE Recall: Covidien, LP — Covidien EndoStitch\" Polysorb Single Use Loading Unit;  Product numbers: 170053 and 170071;","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-15","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2281-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Covidien, LP"},"word_count":100,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2281-2026\n\n**Recalling firm:** Covidien, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-15\n**Report date:** 2026-06-10\n\n## Product\nCovidien EndoStitch\" Polysorb Single Use Loading Unit;  Product numbers: 170053 and 170071;\n\n## Reason\nThe presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and  protect the product from environmental exposure.\n\n## Affected lots\n1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y;  2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;\n\n## Distribution\nDomestic: Nationwide distribution;  International: Austria, Canada, Denmark, France, Italy;"}