Z-1878-2008

Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of...

Name: Z-1878-2008 Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of...
Creator: Medical Device Technologies, Inc.
Published: 2008-05-06
License: https://open.fda.gov/license/

Medical Device Technologies, Inc. / initiated 2008-05-06 / Terminated / root cause: manufacturing process

FDA source

Medical Device Technologies, Inc. began a recall of Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions on 2008-05-06. The reason FDA records is "The sterility of the product cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1878-2008
Status: Terminated
Initiated: 2008-05-06
Posted: 2008-09-25
Terminated: 2011-11-10
Recalling firm: Medical Device Technologies, Inc.
Product: Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: The sterility of the product cannot be guaranteed.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm sent a letter to its consignees on 5/6/08, informing of the recall and requesting that they complete and return by fax the attached customer acknowledgement form. For assistance, contact Medical Device Technologies, Inc., dba Angiotech at 1-352-338-0440 ext. 350 or ext. 353.
Quantity in commerce: 490 units.
Distribution: Nationwide and to Mexico.
Product codes and lots: Lot #; 80281L5V

Product code GAA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)