Tandem Diabetes Care, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1519-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

t:slim X2 Insulin Pump with Interoperable Technology

Product Classification:

Class I

Date Initiated: February 27, 2025

Date Posted: April 23, 2025

Recall Number: Z-1519-2025

Event ID: 96417

Reason for Recall:

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

Status: Ongoing

Product Quantity: 63 units

Code Information:

Software versions 7.9/UDI: 00389152407012

Distribution Pattern:

US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A

Voluntary or Mandated:

Voluntary: Firm initiated