Z-0561-03

Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915

Name: Z-0561-03 Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915
Creator: Boston Medical Products, Inc.
Published: 2003-01-22
License: https://open.fda.gov/license/

Boston Medical Products, Inc. / initiated 2003-01-22 / Terminated / root cause: sterility

FDA source

Boston Medical Products, Inc. began a recall of Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915 on 2003-01-22. The reason FDA records is "Product sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0561-03
Status: Terminated
Initiated: 2003-01-22
Posted: 2003-02-21
Terminated: 2007-10-05
Recalling firm: Boston Medical Products, Inc.
Product: Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915
Reason for recall: Product sterility may be compromised
Root cause tag: sterility
FDA 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 in commerce: 267 units
Distribution: Nationwide
Product codes and lots: Lot Number: 56003 Exp.Date: 7/2005

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)