{"url_path":"/fda/device/recalls/Z-2215-2026","section_key":"summary","section_title":"DEVICE Recall: Medtronic Perfusion Systems — Medtronic GUNDRY Retrograde Cannula  Manual-Inflate  Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2215-2026%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":157,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2215-2026\n\n**Recalling firm:** Medtronic Perfusion Systems\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-21\n**Report date:** 2026-05-27\n\n## Product\nMedtronic GUNDRY Retrograde Cannula  Manual-Inflate  Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter\n\n## Reason\nCertain lots of product have the potential for a sterile barrier breach.\n\n## Affected lots\nGTIN 00643169454521, Lot Numbers:  0231545565, C231958117;  GTIN 20643169454525, Lot Numbers:  0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam."}