Lower riskMedical device recall · FDA · Published June 7, 2021
Pear Therapeutics reSET-O Mobile App: UDS results may not be properly checked for rewards
Pear Therapeutics recalls reSET-O Mobile App for substance abuse treatment. The app may show reward wheel spins for users with positive urine drug screens, which should not happen. Users should contact the company for details.
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.
Take action
Contact the company
📍Recalling firmPear Therapeutics, Inc.201 Mission St Ste 1450 · San Francisco, CA 94105-1882
✎ GovInfoNow plain-language explainer
Pear Therapeutics is recalling their reSET-O Mobile App for iOS and Android. The app could allow users with positive urine drug screen results to access a reward wheel spin, which should not be possible. This could lead to incorrect treatment outcomes. Read more at govinfonow.com/recall/62373-pear-therapeutics-reset-o-mobile-app-uds-results-may-not.
“Pear Therapeutics reSET-O Mobile App: UDS results may not be properly checked for rewards.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62373-pear-therapeutics-reset-o-mobile-app-uds-results-may-not. Based on FDA recall #Z-1926-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2021%22&limit=1).
The FDA announced on June 7, 2021, that Pear Therapeutics, Inc. voluntarily recalled its reSET-O Mobile App for iOS and Android due to a software issue allowing patients with positive urine drug screens to access reward wheels. The recall affects 3,370 units distributed in the U.S.
How to tell if you have it
reSET-O Mobile App, iOS (UPC 10851580008118)
reSET-O Mobile App, Android (UPC 10851580008125)
The hazard
According to the FDA, a software issue allowed patients with a positive urine drug screen to receive access to a contingency management wheel spin for potential rewards regardless of the results. Positive results should not have resulted in access to a wheel spin.
How to tell if you have this one
The reSET-O Mobile App is available on iOS and Android. Check if you have the app installed and if it was purchased after the recall date. The UDI codes are listed in the recall notice.
Brand
Pear Therapeutics
Product
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
Recall number
Product, codes & lots
Quantity
Z-1925-2021
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.; UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1
812 units
Z-1926-2021
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.; UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1
3,370 units
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Pear Therapeutics for specific instructions on how to handle the app.
Where it went and when
Where it was distributed
Distributed in 16 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Minnesota, New York, North Carolina, Ohio, Tennessee, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1926-2021 (June 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1926-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.