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FDA Medical Device Recalls (openFDA)

Wally's Natural Products: 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 number
Z-2487-2010
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.
Status
Terminated
Initiated
2010-02-17
Posted
2010-09-24
Terminated
2011-03-28
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.
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
Not Specified. All
Distribution
Nationwide Distribution
Lot, serial or model codes
All products are under recall
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
Firm FEI
3003165031
Firm city
Auburn
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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