{"recall":{"id":"fda-device-99339","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls 3 products","firm":"AVID Medical, Inc.","date":"2026-04-30","reported":"2026-08-12","status":"Ongoing","classification":"Class I","products":[{"name":"Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05","code":"UDI-DI 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159","quantity":"5168 kits","number":"Z-2796-2026","classification":"Class I"},{"name":"Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15","code":"UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932","quantity":"5168 kits","number":"Z-2797-2026","classification":"Class I"},{"name":"Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05","code":"UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950","quantity":"5168 kits","number":"Z-2798-2026","classification":"Class I"}],"reason":"Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide distribution in the states of NC and TX.","nationwide":true,"states":[],"units":"5168 kits; 5168 kits; 5168 kits","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=99339","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c96449e4fffde815","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=99339","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99339","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US Nationwide distribution in the states of NC and TX.","recall_number":"Z-2796-2026","product_description":"Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.    CARDIAC CATH PACK EAMC1000-05","product_quantity":"5168 kits","reason_for_recall":"Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.","recall_initiation_date":"20260430","center_classification_date":"20260731","report_date":"20260812","code_info":"UDI-DI 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159","more_code_info":""},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99339","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US Nationwide distribution in the states of NC and TX.","recall_number":"Z-2797-2026","product_description":"Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.    SAMMC ANGIOGRAPHY   SAMM066-15","product_quantity":"5168 kits","reason_for_recall":"Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.","recall_initiation_date":"20260430","center_classification_date":"20260731","report_date":"20260812","code_info":"UDI-DI 10809160388495  Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932","more_code_info":""},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99339","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US Nationwide distribution in the states of NC and TX.","recall_number":"Z-2798-2026","product_description":"Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.    HEART CATH,  SELF REGIONAL  SELF131-05","product_quantity":"5168 kits","reason_for_recall":"Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.","recall_initiation_date":"20260430","center_classification_date":"20260731","report_date":"20260812","code_info":"UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950","more_code_info":""}]}}