FDA Medical Device Recalls (openFDA)
Beekley Corporation: Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
- Recall number
- Z-1787-2014
- Recalling firm
- Beekley Corporation
- Product
- Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
- Status
- Terminated
- Initiated
- 2013-06-19
- Posted
- 2014-06-13
- Terminated
- 2014-06-16
- Reason
- Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
- Root cause
- Error in labeling
- Action
- Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491
- Quantity
- 81 boxes
- Distribution
- Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
- Lot, serial or model codes
- Lot Number: 252.04261301
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MUE
- 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