The Recall Desk
HighFDA (Devices)·Z-1925-2021·Announced 2021-06-30

Medical Device Recall: reSET App Grants Rewards Despite Positive Drug Screens

The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a software defect that causes incorrect clinical decision-making. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High classification.

Plain-English summary

The reSET Mobile App (iOS and Android versions) provides cognitive behavioral therapy as part of substance abuse treatment programs. The app includes a contingency management system that uses reward incentives to support treatment adherence.

A software defect caused the app to incorrectly grant patients access to reward incentives regardless of urine drug screen results. Patients with positive test results—indicating continued substance use—should not have been able to access the contingency management rewards, but the bug allowed them to do so. This undermines the clinical logic designed to reinforce abstinence.

Approximately 812 units were distributed across multiple U.S. states. Patients and healthcare providers using the reSET App should contact Pear Therapeutics, the manufacturer, regarding this issue and the availability of a corrected version.

The recalled product

Product
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Manufacturer
Pear Therapeutics, Inc.
Category
Medical Device — Behavioral Health Software
Hazard
Affected units
812

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI Codes: reSET Mobile App
  • iOS (01) 10851580008088 (10) 1 reSET Mobile App
  • Android (01) 10851580008095 (10) 1

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 2 recalled by Pear Therapeutics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Pear Therapeutics, Inc.

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Same hazard · software defect

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