# FDA recall Z-1925-2021

> **Pear Therapeutics, Inc.** · Class II · device recall initiated 2021-06-07.

## Product

reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

## Reason for recall

Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results.  Positive UDS results should not have resulted in access to a wheel spin.

## Distribution

U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI    O.U.S.: N/A

## Key facts

- **Recall number:** Z-1925-2021
- **Recalling firm:** Pear Therapeutics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-07
- **Report date:** 2021-06-30
- **Termination date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2021

## Citation

> AI Analytics. FDA recall Z-1925-2021. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1925-2021. Source: US FDA. Licensed CC0.

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