FDA Recall of Tandem Insulin Pumps Due to User Guide Errors
Tandem Diabetes Care is recalling 1,380 insulin pumps because of translation errors in the Czech language user guide, which could lead to unintended insulin delivery and potential health risks.
What Happened
Tandem Diabetes Care, Inc. has initiated a voluntary recall due to multiple translation errors in the Czech language user guide for their insulin pumps. The most significant error incorrectly instructs users to verify that the infusion set is connected to the body, instead of confirming it is not connected, which could result in unintended insulin delivery and potentially lead to a hypoglycemic event.
Which Products Are Affected
The affected products are Tandem pumps, which are battery-operated infusion pumps for basal and bolus delivery of insulin. Specifically, this involves 1,380 units with Version 7.8.1 and UDI: (01)008500066132625. The recall applies to products distributed internationally in the countries of Czech Republic and Slovakia.
What You Should Do
Consumers who have received the affected Czech language user guide should contact Tandem Diabetes Care, Inc. for further instructions, as the recall was initiated via letter. For returns or refunds, reach out to the firm at their address: 12400 High Bluff Dr, San Diego, CA 92130-3077, using the recall number Z-1636-2026.
Why This Matters
This recall addresses a potential health risk from incorrect user instructions, which could lead to unintended insulin delivery and hypoglycemia, affecting user safety in the specified regions.
Source
Attribution: FDA Recall Notice, event ID 98478, reported on 20260401.
Source: FDA Official Notice