Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both
Summary
The FDA issued a Class I for Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery by Tandem Diabetes Care, Inc.. Reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor fa.
Details
Source
Device Recall
External ID
Z-0427-2026
Action Date
2025-11-12
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 17,745
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-06
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tandem Diabetes Care, Inc. has 22 FDA actions in our database, including 11 recalls and 11 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tandem Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tandem Diabetes Care, Inc. have FDA actions?
Tandem Diabetes Care, Inc. has 22 FDA actions in our database, including 11 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0427-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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