Tandem Mobi recallZ-0427-2026 · Tandem Diabetes Care, Inc. · initiated Oct 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tandem Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
On 10/6/2025, correction notices were mailed or emailed to customers who were informed the following: If your pump shows Malfunction 12, insulin delivery will stop, and the pump becomes non-operational: 1) Promptly acknowledge it by pressing "Silence Alarm". 2) Contact Tandem Diabetes Care Customer Technical Support (CTS) via phone at 1-877-801-6901 or email at [email protected] for further assistance. 3) Switch to your backup method of insulin delivery as directed by your physician. 4) Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. Update 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. The 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. Complete the acknowledgement form using link: https://campaign.tandemdiabetes.com/FCA-Malfunction-12 User Guide: https://www.tandemdiabetes.com/docs/default-source/user-guide/user-guide-tandem-mobi-control-iq-7-9-mgdl-en-us-aw1014938.pdf?sfvrsn=872fc4d7_10
Recall details
- Recall number
- Z-0427-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 6, 2025
- Posted by the FDA
- Nov 5, 2025
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 17,745
- Product code
- QFG
- FDA submissions
- K223213, K233044, K240309, K241078
- Distribution
- 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
Product description
Tandem Mobi Insulin Pump: Description/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). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081
Code information (models, lots, serial numbers)
Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Tandem Mobi 1013655Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths29,532 reports
- Tandem Mobi 1013700Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall1 death6,314 reports
- Tandem Mobi 1013656Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall4,678 reports
- Tandem Mobi 1010750Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall2,031 reports
- Tandem Mobi Starter Kit 1014081Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall1,244 reports
- Tandem Mobi 1012719Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall113 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K223213, K233044, K240309, K241078 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Tandem Mobi, pump, Control-IQ 7.9 1014801Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump2 recalls1 death7,327 reports
- Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ 1014936Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump47 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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