Tandem Diabetes Care is recalling 148 insulin pumps, specifically the t:slim X2 and Tandem Mobi models running software version 7.9. A software defect can cause the pumps to deliver the wrong amount of insulin if they lose connection with a glucose sensor while blood sugar levels are high. Affected units were distributed across 29 U.S. states including California, Texas, and New York between February and April 2025. No injuries have been reported, but consumers should contact the manufacturer to arrange for a software correction.
The software incorrectly calculates glucose trends after a data gap, which can cause the pump to deliver too much or too little insulin. This dosing error can lead to severe hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar), both of which can cause serious medical complications or death.
You have 2 options:
Quantity: 63 units; Recall #: Z-1519-2025
Quantity: 85 units; Recall #: Z-1520-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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