Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: software-defect
incorrect-clinical-logic
reward-access-error
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 →

Same manufacturer · Pear Therapeutics, Inc.

See all →

High
reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access
FDA (Devices) · 2021-06-30

Same hazard · software defect