FDA Medical Device Recalls (openFDA)
Ultracell Medical Technologies: Otocell Ear Wick 15mm Catalog #: BMPEW0915
- Recall number
- Z-0485-03
- Recalling firm
- Ultracell Medical Technologies
- Product
- Otocell Ear Wick 15mm Catalog #: BMPEW0915
- 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
- 506 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: 560003 Exp. 7/2005
- 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
- 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
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