Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operat…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 Mobi7.7/1014081UDI-DI 1010750/00389152075013
What the firm 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 Techsupport@tandemdiabetes.com 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
DistributionShow detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0427-2026
- FDA 510(k) clearance · K223213The device's official FDA premarket clearance record
- FDA 510(k) clearance · K233044The device's official FDA premarket clearance record
- FDA 510(k) clearance · K240309The device's official FDA premarket clearance record
- FDA 510(k) clearance · K241078The device's official FDA premarket clearance record
- FDA device classification · QFGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5730The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Tandem Diabetes Care, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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