Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize
Summary
The FDA issued a Class II for Tandem pumps are battery-operated infusion pumps capable of both basal and bolus by Tandem Diabetes Care, Inc.. Reason: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify tha.
Details
Source
Device Recall
External ID
Z-1636-2026
Action Date
2026-04-01
Status
Ongoing
Category
device
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).
Lot/Code Info: Version 7.8.1/ UDI: (01)008500066132625
Quantity Affected: 1,380 units
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.
Distribution
International distribution in the countries of Czech Republic, Slovakia.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-30
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tandem Diabetes Care, Inc. has 22 FDA actions in our database, including 11 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tandem Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tandem Diabetes Care, Inc. have FDA actions?
Tandem Diabetes Care, Inc. has 22 FDA actions in our database, including 11 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1636-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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