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Tandem pumps are battery-operated infusion pumps capable of… recallZ-1636-2026 · Tandem Diabetes Care, Inc. · initiated Jan 30, 2026

Class II Open, Classified All recalls posted in March 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tandem Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process change control

What the company is doing

On 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.

Recall details

Recall number
Z-1636-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jan 30, 2026
Posted by the FDA
Mar 25, 2026
Recalling firm
Tandem Diabetes Care, Inc.
Quantity
1,380 units
Product code
QFG
FDA submissions
K232380, K232382, K243823, K250792, K250798
Distribution
International distribution in the countries of Czech Republic, Slovakia.

Product description

Tandem 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 (models, lots, serial numbers)

Version 7.8.1/ UDI: (01)008500066132625

Other devices under the same FDA submission

2 devices cleared under K232380, K232382, K243823, K250792, K250798 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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