🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: June 7, 2021 Pear Therapeutics Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Pear Therapeutics, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1

Distribution:

Distributed in: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1925-2021

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