FDA Medical Device Recalls (openFDA)
Medical Device Technologies, Inc.: Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
- Recall number
- Z-1878-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-05-06
- Posted
- 2008-09-25
- Terminated
- 2011-11-10
- Reason
- The sterility of the product cannot be guaranteed.
- 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
- 490 units.
- Distribution
- Nationwide and to Mexico.
- Lot, serial or model codes
- Lot #; 80281L5V
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 1036710
- Firm city
- Gainesville
- Firm state
- FL
- 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