Tandem Diabetes Care Inc: Medical Device Recall in 2022 - (Recall #: Z-1258-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Product Classification:

Class II

Date Initiated: September 10, 2020

Date Posted: June 22, 2022

Recall Number: Z-1258-2022

Event ID: 90113

Reason for Recall:

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

Status: Ongoing

Product Quantity: 5,206

Code Information:

Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier

Distribution Pattern:

International distribution in the country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated