FDA Medical Device Recalls (openFDA)
Beekley Corporation: O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
- Recall number
- Z-2830-2018
- Recalling firm
- Beekley Corporation
- Product
- O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
- Status
- Terminated
- Initiated
- 2018-06-13
- Posted
- not on file
- Terminated
- 2018-11-13
- Reason
- There is a potential for imaging artifact to mimic calcifications on patient's mammograms
- Root cause
- Nonconforming Material/Component
- Action
- On June 14, 2018, Beekley Medical issued an "URGENT MEDICAL DEVICE RECALL" notice dated June 13, 2018 to customers. The notice described the products, problem and actions to be taken. Customers are advised to do the following: - Inspect stock and quarantine affected product - complete and return the acknowledgement response form via fax to: 1-800-735-1234 or mail. - contact firm if inventory of affected product remains with customers at 1-800-233-5539 between 8:00am - 5:30pm EDT. If you have any issues occurred or for further question, contact Quality Assurance & Regulatory Manager at 1-800-233-5539x434.
- Quantity
- 3,384,024 pieces in total.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
- Lot, serial or model codes
- REF 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271801 05291802 03081801 03091801 05111801 05251801 04091801 02201801 02231801 02071801 02091801 03161802 03231801 02131801 05031801 03011801 03291801 04301801 05171801 04161801 04261801 02051801 04051801 03201801 03221801 02151801 03221802 02021801 05231802 05021801 04191802 05291801 04301802 05211802 02191802 REF 791S - Lot Numbers: 03191801 02221802
- 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
- 2026-10-14
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