{"url_path":"/fda/device/recalls/Z-2222-2026","section_key":"summary","section_title":"DEVICE Recall: Medtronic Perfusion Systems — Medtronic DLP Retrograde Cannula   Manual-Inflate   Silicone Body 15FR, Model 94965; 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-2222-2026%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":124,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2222-2026\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 DLP Retrograde Cannula   Manual-Inflate   Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter\n\n## Reason\nCertain lots of product have the potential for a sterile barrier breach.\n\n## Affected lots\nGTIN 20643169454815, Lot Numbers:  0231665658, C231786900.\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."}