A problem with a false occlusion alarm could interrupt insulin delivery for users, according to an entry in the FDA’s recall database.

The latest recall applies to more than 80,900 Mobi devices, most of which were distributed in the U.S., according to the FDA’s database entry. While the database provided a list of serial numbers for pumps with frequent false alarms to be exchanged, the entry also noted that “all affected pump models and serial numbers may be affected.”

Tandem found that increased friction within the pumps’ drive module can reduce available motor power, and under certain conditions, may cause the motor speed to fall below the occlusion detection threshold, triggering a false alarm. The company has told customers that they may continue to use their Mobi devices, but must always respond to an occlusion alarm and have a backup method of insulin delivery. If the occlusion alarms continue after troubleshooting, or repeatedly disrupt insulin therapy, Tandem has instructed users to contact customer support.

Tandem is investigating the issue and has taken steps during testing to prevent the problem in the future, a spokesperson wrote in an email.

Tandem grappled with a separate software malfunction a year ago that could affect insulin delivery from its Mobi devices, instructing users to install an update to fix the issue. The company sent a letter to customers in October 2025, but the FDA posted it in its recall database in April.

A tubeless option for Mobi is in the late stages of FDA review, CEO John Sheridan said in an earnings call last week.

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