The Recall Desk
HighFDA (Devices)·Z-1926-2021·Announced 2021-06-30

reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access

Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.

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: FDA Class II medical device recall. The software defect creates a risk of harm by allowing patients with positive drug test results to receive rewards despite not meeting program requirements, which may undermine treatment efficacy. No illnesses or injuries have been reported.

Plain-English summary

reSET-O is a mobile application for iOS and Android devices that provides cognitive behavioral therapy as part of substance abuse treatment programs. The app includes a contingency management feature that provides rewards to patients based on urine drug screen (UDS) results.

Due to a software defect, the app incorrectly allowed patients who tested positive on urine drug screens to access the contingency management reward system. Under normal operation, patients with positive UDS results should not have been eligible for these rewards.

The recall affects approximately 3,370 units distributed across the United States in Arizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Tennessee, Washington, and Wisconsin.

Patients and healthcare providers using this app should contact Pear Therapeutics for information about the software update or alternative treatment options while the defect is being corrected.

The recalled product

Product
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Manufacturer
Pear Therapeutics, Inc.
Category
Medical Device — Mental Health / Substance Abuse Treatment Software
Hazard
Affected units
3,370

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-O Mobile App
  • iOS (01) 10851580008118 (10) 1 reSET-O Mobile App
  • Android (01) 10851580008125 (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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