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FDA Medical Device Recalls (openFDA)

Ultracell Medical Technologies: Ultracell Ear Wick 9mm DIA x 24 mm Catalog #: 30310-C

Recall number
Z-0483-03
Recalling firm
Ultracell Medical Technologies
Product
Ultracell Ear Wick 9mm DIA x 24 mm Catalog #: 30310-C
Status
Terminated
Initiated
2003-01-08
Posted
2003-01-30
Terminated
2012-05-01
Reason
Sterility of the device is compromised
Root cause
Other
Action
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
Quantity
106 boxes
Distribution
Nationwide
Lot, serial or model codes
Lot numbers: 063204 Exp. 7/2005  063206 Exp. 8/2005
510(k) numbers
["K920357"]
PMA numbers
not on file
Product code
KCN
Firm FEI
1000120594
Firm city
North Stonington
Firm state
CT
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
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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