reSET-O® Mobile App, Android 1Recalls & reported problems
Pear Therapeutics, Inc. · reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K173681); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 7, 2021Terminated
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.
Z-1926-2021 · Root cause: Software design · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173681. One submission often covers many models, so check the product and lot details in each record.
- Z-1925-2021 · Jun 7, 2021 · TerminatedreSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Other Computerized Behavioral Therapy Device For Psychiatric Disorders devices
- reSET® Mobile App, Android 1Pear Therapeutics, Inc. · Computerized Behavioral Therapy Device For Psychiatric Disorders1 recall0 reports
- reSET® Mobile App, iOS 1Pear Therapeutics, Inc. · Computerized Behavioral Therapy Device For Psychiatric Disorders1 recall0 reports
- reSET-O® Mobile App, iOS 1Pear Therapeutics, Inc. · Computerized Behavioral Therapy Device For Psychiatric Disorders1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page