Z-1636-2026Class II

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

Name: Z-1636-2026 Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The...
Creator: Tandem Diabetes Care, Inc.
Published: 2026-01-30
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2026-01-30 / Open, Classified

FDA source

Tandem Diabetes Care, Inc. began a recall of 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... on 2026-01-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1636-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-30
Posted: 2026-03-25
Recalling firm: Tandem Diabetes Care, Inc.
Product: 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).
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
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 root cause: Process change control
Action: 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.
Quantity in commerce: 1,380 units
Distribution: International distribution in the countries of Czech Republic, Slovakia.
Product codes and lots: Version 7.8.1/ UDI: (01)008500066132625

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1636-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1636-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-25

Product code QFG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)