Class II — Beekley Corporation
| Recalling firm | Beekley Corporation |
|---|---|
| Registered facility | Beekley Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| Product | O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. |
| 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. |
| Initiated | 2018-06-13 |
| Classified | 2018-08-16 |
| Terminated | 2018-11-13 |
| Recall number | Z-2830-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beekley Corporation (Z-2830-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80558/
Alerts for Beekley Corporation
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.