Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2487-2010

Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties...

Wally's Natural Products / initiated 2010-02-17 / Terminated

Wally's Natural Products began a recall of Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2487-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wally's Natural Products
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.
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 root 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
Product codes and lots
All products are under recall