🔍 RecallPedia

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Class I - Dangerous
🏥 Medical Devices Recalled: May 23, 2023 Young Dental Manufacturing I Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00366975000590, Lot number 207540, Exp. 20240930
  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:
Young Dental Manufacturing I, LLC
Reason for Recall:
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Product Codes/Lot Numbers:

UDI/DI 00366975000590, Lot number 207540, Exp. 20240930

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1697-2023

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