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U.S. Department of Health and Human Services

Class 2 Device Recall t:slim X2 insulin pump with interoperable technology

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 Class 2 Device Recall t:slim X2 insulin pump with interoperable technologysee related information
Date Initiated by FirmJanuary 30, 2026
Date PostedMarch 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1636-2026
Recall Event ID 98478
510(K)NumberK232380 K232382 K243823 K250792 K250798 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductTandem 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).
Code Information Version 7.8.1/ UDI: (01)008500066132625
FEI Number 3007981285
Recalling Firm/
Manufacturer		 Tandem Diabetes Care, Inc.
12400 High Bluff Dr
San Diego CA 92130-3077
For Additional Information ContactMs. Susan Morrison
877-801-6901
Manufacturer Reason
for Recall		The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
FDA Determined
Cause 2		Process change control
ActionOn January 30, 2026, Tandem Diabetes Care issued a Urgent Medical Device Recall Notice to affected consignees via E-Mail. Tandem ask consignees to take the following actions: 1. Discard your existing User Guide. 2. Refer to the corrected User Guide version 7.8.1 which is available online at www.tandemdiabetes.com/cs-cz/support/resources/documents for accurate instructions on using your t:slim X2 Insulin Pump. 3. Physical copies of the corrected User Guide are being produced to replace the incorrect versions. If you would like a physical copy of the corrected User Guide, you may contact A. Import s customer service line to arrange for a replacement. 4.As requested above, please complete the online form acknowledging receipt of this notice. 5. Should you experience any device-related serious incidents, please report them to your distributor, a local contact point, or the State Institute for Drug Control.
Quantity in Commerce1,380 units
DistributionInternational distribution in the countries of Czech Republic, Slovakia.
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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