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.
- Hazard
- software-defect
- incorrect-clinical-logic
- reward-access-error
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:
- AZ
- CA
- DE
- FL
- IL
- IN
- KY
- MA
- MD
- MN
- NC
- NY
- OH
- TN
- WA
- WI
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