Class 2 Device Recall Wally's Ear Candles

• Date Initiated by Firm: February 17, 2010
• Date Posted: September 24, 2010
• Recall Status: Terminated on March 28, 2011
• Recall Number: Z-2487-2010
• Recall Event ID: 56423
• Product: Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA.
• Code Information: All products are under recall
• Recalling Firm/ Manufacturer: Wally's Natural Products; 11837 Kemper Rd Ste 5; Auburn CA 95603-9067
• Manufacturer Reason for Recall: Product is an unapproved medical device. Use as directed may result in accidental damage to the eardrum, leading to injuries up to loss of hearing.
• FDA Determined Cause: Other
• Action: The firm conducted communications via phone, mail and website, stating that they have stopped manufacturing and distributing ear candles, and asks consumers to return for a refund.
• Quantity in Commerce: Not Specified. All
• Distribution: Nationwide Distribution

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.