FDA Recall
Terminated
Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA.
Recall: Z-2487-2010
·
Initiated February 17, 2010
Recall
- Recall Number
- Z-2487-2010
- Event Number
- 56423
- Firm
- Wally's Natural Products
- FEI Number
- 3003165031
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 17, 2010
- Posted
- September 24, 2010
- Terminated
- March 28, 2011
- Address
- 11837 Kemper Rd, Ste 5, Auburn, CA, 95603-9067
Description
Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA.
Reason
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.
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.
Distribution
Nationwide Distribution
Quantity
Not Specified. All