FDA Medical Device Recalls (openFDA)
Boston Medical Products, Inc.: Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915
- Recall number
- Z-0561-03
- Recalling firm
- Boston Medical Products, Inc.
- Product
- Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915
- Status
- Terminated
- Initiated
- 2003-01-22
- Posted
- 2003-02-21
- Terminated
- 2007-10-05
- Reason
- Product sterility may be compromised
- Root cause
- Other
- Action
- Boston Medical Products notified their accounts by letter on 1/22/03. Users are requested to discard product and complete reply form.
- Quantity
- 267 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: 56003 Exp.Date: 7/2005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1219795
- Firm city
- Westborough
- Firm state
- MA
- 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