Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize

FDA device recall Z-1636-2026 · posted 2026-03-25 · Open, Classified

Recall details

Recalling firm

Tandem Diabetes Care, Inc.

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.

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

QFG

Quantity affected

1,380 units

Distribution

International distribution in the countries of Czech Republic, Slovakia.

Date initiated

2026-01-30

Date posted

2026-03-25

Location

San Diego, CA

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