FDA Medical Device Recalls (openFDA)
Beekley Corporation: Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
- Recall number
- Z-2109-2012
- Recalling firm
- Beekley Corporation
- Product
- Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
- Status
- Terminated
- Initiated
- 2012-07-09
- Posted
- 2012-07-31
- Terminated
- 2013-07-09
- Reason
- Digital Skin Mammography Marker separating from the backing of the spot material
- Root cause
- Unknown/Undetermined by firm
- Action
- Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form.
- Quantity
- 36,518 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: A020, A021, A022, A023, A024, AO25, A026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAC
- Firm FEI
- 3000204334
- Firm city
- Bristol
- 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