Z-1925-2021Class II

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

Name: Z-1925-2021 reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment
Creator: Pear Therapeutics, Inc.
Published: 2021-06-07
License: https://open.fda.gov/license/

Pear Therapeutics, Inc. / initiated 2021-06-07 / Terminated / root cause: software

FDA source

Pear Therapeutics, Inc. began a recall of reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment on 2021-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1925-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-07
Posted: 2021-06-21
Terminated: 2023-06-14
Recalling firm: Pear Therapeutics, Inc.
Product: reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Product code: PWE Computerized Behavioral Therapy Device For Substance Use Disorders
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.
Root cause tag: software
FDA root cause: Software design
Action: On 05/20/2021, the Recalling Firm communicated via email an initial "URGENT: MEDICAL DEVICE RECALL" Notification with an amended/follow-up Notification Letter sent on or about 06/07/2021 informing customers that between 08/10/2020 and 04/30/2021, patients with a urine drug screen (UDS) logged into the Recalling Firm's database 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. Customers are also being informed that there are no actions required for the safe handling of the corrected product. A software release was issued on 04/30/2021 to return the products to their intended operation. Given the potential for reduced clinical effectiveness, Healthcare Providers are encouraged to review patients that have a positive urine drug screen logged to ensure that the patient receives any treatment or counseling necessary to support the patient's treatment. Customers are asked to complete and return the "REPLY FORM" via Fax at 415-458-2700 (Attn: Yuri Maricich) or email to [email protected]. For questions or further assistance, call 1-833-697-3738 (available weekdays 8:00 a.m. - 8:00 p.m. EST)
Quantity in commerce: 812 units
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
Product codes and lots: UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1926-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21

Product code PWE

K173681Class IIreSET-OPear Therapeutics, Inc. / cleared 2018-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)