San Francisco, CA, United States
Pear Therapeutics, Inc. recalls
1 recall recorded since 2018, most recently on 7 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 June 2021
- Terminated
- 14 June 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1926-2021, Z-1925-2021
- reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
- reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.