Tandem Mobi Insulin Pump: Description/Catalog: Tandem recall: Software Issue
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of…
Why was Tandem Mobi Insulin Pump: Description/Catalog: Tandem 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of…
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 17,745
- 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
- Recall date
- November 12, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)