Non-ablative Fractional Laser Systems, Model: WFB-01

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
  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:
WINGDERM ELECTRO-OPTICS LTD.
Reason for Recall:
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Non-ablative Fractional Laser Systems, Model: WFB-01

Product Codes/Lot Numbers:

F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0555-2025

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