{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215011", "product_res_number": "Z-2621-2025", "event_date_initiated": "2025-07-03", "event_date_posted": "2025-09-24", "recall_status": "Open, Classified", "res_event_number": "97264", "product_code": "QFG", "k_numbers": [ "K232380" ], "product_description": "t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)", "code_info": "Tandem t:slim Mobile App, Android Software Version 2.9.1\nUDI-DI code: 00389152470641\nSerial Numbers / Cell Phone OS:\n1163923\tGoogle Pixel 8 Pro husky [15 35]\n1164430\tsamsung SM-S901E r0qxxx [15 35]\n1167131\tsamsung SM-A346E a34xdxx [14 34]\n1299238\tsamsung SM-G780G r8qxx [13 33]\n1300180\tsamsung SM-S928B e3qxxx [15 35]\n1300180\tsamsung SM-S928B e3qxxx [14 34]\n1329242\tGoogle Pixel 6 Pro raven [15 35]\n1381313\tsamsung SM-G780G r8qxx [13 33]\n1381315\tGoogle Pixel 9 tokay [16 36]\n1381537\tsamsung SM-A546E a54xnsxx [14 34]\n1381570\tXiaomi 2407FPN8EG rothko_global [15 35]\n1391808\tsamsung SM-S711B r11sxxx [14 34]\n1391892\tsamsung SM-N980F c1sxx [13 33]\n1392863\tsamsung SM-S926B e2sxxx [15 35]\n1392953\tsamsung SM-S916B dm2qxxx [15 35]\n1393040\tsamsung SM-S901E r0qxxx [15 35]\n90615975\trealme RMX3241 RMX3241 [13 33]\n90754587\tsamsung SM-S916B dm2qxxx [15 35]\n901144584\tsamsung SM-S901E r0qxxx [14 34]", "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": "an app\ndefect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and\ngraphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or\nhyperglycemia.", "root_cause_description": "Software design", "action": "On 07/03/2025, the firm sent an \"URGENT FIELD SAFETY NOTICE\" it distributor to notify customers that users operating an Android phone with language setting set as Hebrew may experience a blank screen on the mobile application during the initial pairing sequence. The language setting must be set to English for the pairing sequence to work successfully. However, if users set their language back to a right-to-left language after pairing, or do not encounter the initial issue, the mobile application will display discrepancies. This discrepancy may cause a user to make incorrect therapy decisions that may result in under-delivery or over-delivery of insulin.\n\nCustomers are instructed to:\nIf you are operating the Tandem t:slim mobile app version 2.9.1 on an Android smartphone, and your device language is set to a right-to-left language, please revert your phone language setting to English. You can do this by navigating to the Settings app on your device.\nIf you are unable to or do not want to change your phone language to English, Tandem\nrecommends not to use the Android Tandem t:slim mobile app version 2.9.1 until a future\nupdate addresses this issue.\nAdditional Recommended Best Practices:\n1. Continue using your Tandem pump as described in the User Guide.\n2. Regularly check your blood sugar to ensure you are not having unexpectedly high or\nlow readings.\n3. Pay attention to all system alerts and alarms.\n4. Always carry back-up supplies.\n\nFor questions or assistance - Additional information of this Field Safety Notice is available by contacting Padagis at Inbal.hadasheli@padagis.com.", "product_quantity": "19", "distribution_pattern": "International distribution to the country of Israel.", "openfda": { "k_number": [ "K250930", "K253976", "K191679", "K203768", "K253074", "K231485", "K250792", "DEN180058", "K213134", "K230545", "K260001", "K253743", "K223846", "K251032", "K261672", "K233952", "K213536", "K240309", "K231826", "K234027", "K241078", "K241178", "K223213", "K253470", "K232380", "K203234", "K201214", "K252770", "K233044" ], "device_name": "Alternate Controller Enabled Insulin Infusion Pump", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "880.5730", "device_class": "2", "registration_number": [ "2022435", "3013756811", "2032098", "3014585508", "3019807891", "3010291427", "2246552", "3014197758", "2024024", "2030598", "1220973", "3016245399", "3016798778", "3026266833", "3030970576", "2032227", "1220477", "3047799708", "3032746481", "3015192982", "3007981285", "3044561902", "3042027705", "3005627859", "3016540876", "2030624", "2029275", "3019004087", "3008824097" ], "fei_number": [ "2022435", "3013756811", "3014585508", "3019807891", "3000206435", "3010291427", "2246552", "3014197758", "2024024", "3003166194", "1220973", "3016245399", "1000306431", "3003058448", "3016798778", "1000518731", "3026266833", "3030970576", "1220477", "3047799708", "3032746481", "3015192982", "3007981285", "3044561902", "3042027705", "3005627859", "3016540876", "3019004087", "3008824097" ] } } ] }