🔍 RecallPedia

CustMbite, Model Number CBT-SRS-UL

Class I - Dangerous
🏥 Medical Devices Recalled: May 23, 2022 Dental Choice Holding Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
  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:
Dental Choice Holding Llc
Reason for Recall:
The device was marketed and sold in the US without FDA clearance.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CustMbite, Model Number CBT-SRS-UL

Product Codes/Lot Numbers:

UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1494-2022