FDA Medical Device Recalls (openFDA)
Pear Therapeutics, Inc.: reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
- Recall number
- Z-1926-2021
- Recalling firm
- Pear Therapeutics, Inc.
- Product
- reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
- Status
- Terminated
- Initiated
- 2021-06-07
- Posted
- not on file
- Terminated
- 2023-06-14
- Reason
- 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
- 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 postmarked@peartherapeutics.com. For questions or further assistance, call 1-833-697-3738 (available weekdays 8:00 a.m. - 8:00 p.m. EST)
- Quantity
- 3,370 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
- Lot, serial or model codes
- UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1
- 510(k) numbers
- ["K173681"]
- PMA numbers
- not on file
- Product code
- PWE
- Firm FEI
- 3014109807
- Firm city
- San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28