Pear Therapeutics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1926-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 7, 2021

Date Posted: June 30, 2021

Recall Number: Z-1926-2021

Event ID: 88061

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.

Status: Terminated

Product Quantity: 3,370 units

Code Information:

UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1

Distribution Pattern:

U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A

Voluntary or Mandated:

Voluntary: Firm initiated