reSET-O Mobile App — Class II medical device recall Z-1926-2021
Terminated recall by Pear Therapeutics, Inc., reported 2021-06-30, distributed in AZ, CA, DE, FL, IL, IN, KY, MA…. Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management w
| Recall number | Z-1926-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pear Therapeutics, Inc., San Francisco, CA, United States |
| Recall initiated | 2021-06-07 |
| Classified | 2021-06-21 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-06-14 |
| Distributed | AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, WI |
| Quantity | 3,370 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10851580008118, 10851580008125 |
Product
reSET-O 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1926-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.