{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216259", "product_res_number": "Z-0427-2026", "event_date_initiated": "2025-10-06", "event_date_posted": "2025-11-05", "recall_status": "Open, Classified", "res_event_number": "97662", "product_code": "QFG", "k_numbers": [ "K223213", "K233044", "K240309", "K241078" ], "product_description": "Tandem Mobi Insulin Pump:\nDescription/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).\nPump, Tandem Mobi, Control-IQ/1010750,\nPump, Tandem Mobi, Control-IQ, Replacement/1012719,\nPump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,\nPump, Tandem Mobi, Control-IQ 7.7/1013655,\nPump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,\nPump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,\nPharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081", "code_info": "Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1\nCatalog/UDI-DI:\n1010750/00389152075013,\n1012719/00389152271910,\n1013501/00389152350110,\n1013655/00389152365510,\n1013656/00389152365619,\n1013700/00389152370019,\n1014081/00389152408170", "firm_fei_number": "3007981285", "recalling_firm": "Tandem Diabetes Care, Inc.", "address_1": "12400 High Bluff Dr", "city": "San Diego", "state": "CA", "postal_code": "92130-3077", "additional_info_contact": "Ms Susan Morrison\n858-366-6880", "reason_for_recall": "Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: \"Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped\", which could result in hyperglycemia.", "root_cause_description": "Software design", "action": "On 10/6/2025, correction notices were mailed or emailed to customers who were informed the following:\n\nIf your pump shows Malfunction 12, insulin delivery will stop, and the pump becomes non-operational:\n1) Promptly acknowledge it by pressing \"Silence Alarm\". \n2) Contact Tandem Diabetes Care Customer Technical Support (CTS) via phone at 1-877-801-6901 or email at Techsupport@tandemdiabetes.com for further assistance. \n3) Switch to your backup method of insulin delivery as directed by your physician.\n4) Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings.\n\nUpdate your pump software as soon as possible to version 7.9.0.2. You can check your software version within the Mobi Mobile App. Select Settings > Pump > Pump Info.\n\nThe latest software can be downloaded remotely from within the Tandem Mobi Mobile App. Once logged in to the app, tap \"Settings\" and then \"Pump\" to view software updates.\n\nComplete the acknowledgement form using link: https://campaign.tandemdiabetes.com/FCA-Malfunction-12\n\nUser Guide:\nhttps://www.tandemdiabetes.com/docs/default-source/user-guide/user-guide-tandem-mobi-control-iq-7-9-mgdl-en-us-aw1014938.pdf?sfvrsn=872fc4d7_10", "product_quantity": "17,745", "distribution_pattern": "US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY", "openfda": { "k_number": [ "K203234", "K213536", "K230545", "K253743", "K253074", "K203768", "K250792", "K253470", "K223213", "K241078", "K234027", "K232380", "K233952", "K261672", "K231485", "K253976", "K201214", "K213134", "K241178", "K250930", "K223846", "K191679", "DEN180058", "K252770", "K233044", "K231826", "K251032", "K240309" ], "registration_number": [ "3016798778", "3047799708", "2030598", "3042027705", "3019807891", "3014197758", "3008824097", "3015192982", "2029275", "2032098", "3032746481", "3007981285", "3005627859", "3016245399", "2246552", "1220973", "2022435", "3014585508", "3019004087", "2024024", "3016540876", "3026266833", "1220477", "3044561902", "2030624", "3010291427", "2032227", "3030970576", "3013756811" ], "fei_number": [ "3016798778", "3047799708", "3042027705", "3019807891", "3003166194", "3014197758", "3008824097", "3015192982", "1000306431", "3032746481", "3007981285", "3005627859", "3016245399", "2246552", "1220973", "2022435", "3014585508", "3019004087", "2024024", "3016540876", "3000206435", "1220477", "3044561902", "3026266833", "1000518731", "3003058448", "3010291427", "3030970576", "3013756811" ], "device_name": "Alternate Controller Enabled Insulin Infusion Pump", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "880.5730", "device_class": "2" } } ] }