reSET-O® Mobile App, iOS 1Recalls & reported problems

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

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