Tandem Diabetes Care, Inc.: t:slim X2 insulin pumps — FDA announcement Aug 12, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 12, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
t:slim X2 insulin pumps
Reason
Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery
Classification
Not supplied
Recalling firm
Tandem Diabetes Care, Inc.
Quantity
Not supplied
Agency-reported status
Company recall announcement
Source record identifier
ce384bedb6de0cc4

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Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityNot supplied

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date
Aug 12, 2025
Company announcement date
Aug 7, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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