FDA Device recall Z-1926-2021
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment by Pear Therapeutics, citing 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. Positi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1926-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-07 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Pear Therapeutics |
| Distribution | AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, WI |
Product
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
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.
Identifiers
| code_info | UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2021%22
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