{"url_path":"/fda/device/recalls/Z-2575-2026","section_key":"summary","section_title":"DEVICE Recall: Medtronic Perfusion Systems — Octopus Evolution Tissue Stabilizer, Model TS2000","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-12","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2575-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medtronic Perfusion Systems"},"word_count":92,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2575-2026\n\n**Recalling firm:** Medtronic Perfusion Systems\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-12\n**Report date:** 2026-07-01\n\n## Product\nOctopus Evolution Tissue Stabilizer, Model TS2000\n\n## Reason\nDuring the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.\n\n## Affected lots\nUDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115\n\n## Distribution\nWorldwide - US Nationwide distribution."}