{"recall":{"id":"fda-device-99199","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medtronic Perfusion Systems recalls 2 products","firm":"Medtronic Perfusion Systems","date":"2026-05-25","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula","code":"MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220","quantity":"","number":"Z-2738-2026","classification":"Class II"},{"name":"Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula","code":"MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001","quantity":"","number":"Z-2739-2026","classification":"Class II"}],"reason":"Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.","nationwide":true,"states":[],"units":"","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99199","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"33d968b3ab7945ac","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99199","record":[{"status":"Ongoing","city":"Brooklyn Park","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99199","recalling_firm":"Medtronic Perfusion Systems","address_1":"7611 Northland Dr N","address_2":"","postal_code":"55428-1088","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.","recall_number":"Z-2738-2026","product_description":"Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula","product_quantity":"","reason_for_recall":"Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.","recall_initiation_date":"20260525","center_classification_date":"20260715","report_date":"20260722","code_info":"MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220","more_code_info":""},{"status":"Ongoing","city":"Brooklyn Park","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99199","recalling_firm":"Medtronic Perfusion Systems","address_1":"7611 Northland Dr N","address_2":"","postal_code":"55428-1088","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.","recall_number":"Z-2739-2026","product_description":"Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula","product_quantity":"","reason_for_recall":"Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.","recall_initiation_date":"20260525","center_classification_date":"20260715","report_date":"20260722","code_info":"MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001","more_code_info":""}]}}