{"recall":{"id":"fda-device-99801","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Cardinal Health 200, LLC recalls Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366","firm":"Cardinal Health 200, LLC","date":"2026-08-19","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G","code":"AN23366084 UDI-DI 10197106950074 Kit lot 40711 AN23366085 UDI-DI 10198956177987 Kit lot 46520 AN2336608H UDI-DI 10197106159828 Kit lots 20866 23139 24264 25795 27111 27899 29023 29488 30527 31037 31698 32777 33326 AN2336608J UDI-DI 10197106704035 Kit lots 33461 33624 35231 35535 35689 36554 36600 36825 38327 38891 40511 41864 43975 44933 45972 47547 47897 48088 48528 49440 OMSVM4166A UDI-DI 10198956162259 Kit Lots 47765 50521 53221 53929 54565 54644 AN2336608G UDI-DI 10197106052105 Kit lots 18464 18569 19224","quantity":"210 total kits","number":"Z-0079-2027","classification":"Class II"}],"reason":"Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Pending","nationwide":false,"states":[],"units":"210 total 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=99801","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"47e2745e37ca7ad9","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=99801","record":[{"status":"Ongoing","city":"Waukegan","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99801","recalling_firm":"Cardinal Health 200, LLC","address_1":"3651 Birchwood Dr","address_2":"N/A","postal_code":"60085-8337","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Pending","recall_number":"Z-0079-2027","product_description":"Presource Packs containing Medtronic Microstream Components:    Intubation Kit  Catalog Numbers   AN23366084  AN23366085  AN2336608H  AN2336608J    Intubating Bag Kit  Catalog Number OMSVM4166A    Intubation UH Kit  Catalog Number AN2336608G","product_quantity":"210 total kits","reason_for_recall":"Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.","recall_initiation_date":"20260819","center_classification_date":"20261002","report_date":"20261014","code_info":"AN23366084    UDI-DI 10197106950074    Kit lot 40711  AN23366085    UDI-DI 10198956177987    Kit lot 46520  AN2336608H    UDI-DI 10197106159828    Kit lots                 20866   23139   24264   25795   27111   27899   29023   29488   30527   31037   31698   32777   33326  AN2336608J    UDI-DI 10197106704035    Kit lots                 33461   33624   35231   35535   35689   36554   36600   36825   38327   38891   40511   41864   43975   44933   45972   47547   47897   48088   48528   49440    OMSVM4166A    UDI-DI 10198956162259    Kit Lots                 47765   50521   53221   53929   54565   54644    AN2336608G    UDI-DI 10197106052105    Kit lots                 18464   18569   19224"}]}}