CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
reSET Mobile App, iOS and Android recalled by Pear Therapeutics
Pear Therapeutics is recalling reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of, distributed in 16 states. The recall was initiated on 7 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1925-2021
- FDA event ID
- 88061
- Recalling firm
- Pear Therapeutics, San Francisco, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2021
- FDA classified
- 21 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 7 Jun 2021 | Recall initiated by company | |
| 21 Jun 2021 | Classified by FDA | +14 days |
| 30 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Where it was distributed
U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
ArizonaCaliforniaDelawareFloridaIllinoisIndianaKentuckyMassachusettsMarylandMinnesotaNorth CarolinaNew YorkOhioTennesseeWashingtonWisconsin
Questions about this recall
Is reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of recalled?
Yes. Pear Therapeutics recalled reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of on 7 Jun 2021. The recall is Class II and its status is Terminated. Recall number Z-1925-2021.
Why was it recalled?
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.
Which lots are affected?
UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1
Where was it sold?
U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pear Therapeutics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | reSET-O Mobile App, iOS and Android recalled by Pear Therapeutics | Pear Therapeutics | Device Malfunction | 16 states |
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| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |