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U.S. Department of Health and Human Services

Class 2 Device Recall Tandem Mobi Insulin Pump with Interoperable Technology (with Android Tandem Mobi Mobile app)

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 Class 2 Device Recall Tandem Mobi Insulin Pump with Interoperable Technology (with Android Tandem Mobi Mobile app)see related information
Date Initiated by FirmOctober 13, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0437-2027
Recall Event ID 100091
510(K)NumberK253074 K223213 K240309 K241078 K233044 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductTandem Mobi Insulin Pump with Interoperable Technology (with Android Tandem Mobi Mobile app) Model/Catalog Number: 1015472
Code Information Lot Code: UDI-DI: 00389152547244 Software versions: 3.5.4, 3.5.2.2, and 3.5.2.1
FEI Number 3007981285
Recalling Firm/
Manufacturer		 Tandem Diabetes Care, Inc.
12400 High Bluff Dr
San Diego CA 92130-3077
For Additional Information ContactSusan Morrison
1-858-3666880
Manufacturer Reason
for Recall		A software defect in the Tandem Mobi mobile application for Android (versions 3.5.4, 3.5.2.2, and 3.5.2.1) in which the immediate ( Now ) portion of an Extended Bolus is incorrectly reduced to 0 units when the entered glucose value equals the user s active target glucose value; the deferred ( Later ) portion is delivered, but the total insulin delivered may be less than intended, and the application does not provide a distinct alert that the immediate portion was omitted, potentially resulting in unrecognized under-delivery of insulin and hyperglycemia.
FDA Determined
Cause 2		Software design
ActionOn October 13, 2026, Tandem Diabetes Care issued a Urgent Medical Device Correction via email. Tandem ask consignees to take the following actions: 1. Do not use the Extended Bolus feature if you are using the Tandem Mobi mobile app on Android. You may continue to use the Standard Bolus feature. 2. You may continue using the Tandem Mobi mobile app on Android for other available functions. 3. Share this notification with caregivers or anyone else who may be using the Tandem Mobi mobile app on Android. 4. Acknowledge receipt of this letter via the QR code/link above.
Quantity in Commerce4086 users
DistributionWorldwide - US Nationwide and the country of Czech Republic.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QFG
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