t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

Recall Insight

This FDA Devices action (record #Z-1609-2024) was formally reported on May 15, 2024, with the manufacturer initiating the action on March 5, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Tandem Diabetes Care, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records indicate 85,863 applications units are affected.

The documented reason for this recall is: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in… Distribution data in the federal record shows the product reached: US nationwide distribution including Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.