FDA Medical Device Recalls (openFDA)
Beekley Corporation: Beekley Medical 0-SPOT Mammography Skin Markers REF 652
- Recall number
- Z-2309-2017
- Recalling firm
- Beekley Corporation
- Product
- Beekley Medical 0-SPOT Mammography Skin Markers REF 652
- Status
- Terminated
- Initiated
- 2017-05-08
- Posted
- not on file
- Terminated
- 2017-06-20
- Reason
- Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
- Root cause
- Employee error
- Action
- Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434.
- Quantity
- 104 boxes (58/box)= 6,032 total units
- Distribution
- US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
- Lot, serial or model codes
- LOT 652.04251701
- 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