{"recall":{"id":"fda-device-99557","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Baxter Healthcare Corporation recalls 2 products","firm":"Baxter Healthcare Corporation","date":"2026-08-11","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS","code":"UDI-DI 05413765852428, all serial numbers","quantity":"14601 units","number":"Z-3065-2026","classification":"Class II"},{"name":"Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL","code":"UDI-DI 00197886002300, all serial numbers","quantity":"4 units","number":"Z-3066-2026","classification":"Class II"}],"reason":"A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.","nationwide":true,"states":[],"units":"14601 units; 4 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=99557","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"28d05bebf12da70b","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=99557","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99557","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"N/A","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.","recall_number":"Z-3065-2026","product_description":"Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS","product_quantity":"14601 units","reason_for_recall":"A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.","recall_initiation_date":"20260811","center_classification_date":"20260831","report_date":"20260909","code_info":"UDI-DI 05413765852428, all serial numbers","more_code_info":""},{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99557","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"N/A","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.","recall_number":"Z-3066-2026","product_description":"Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL","product_quantity":"4 units","reason_for_recall":"A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.","recall_initiation_date":"20260811","center_classification_date":"20260831","report_date":"20260909","code_info":"UDI-DI 00197886002300, all serial numbers","more_code_info":""}]}}