Class II — Beekley Corporation
| Recalling firm | Beekley Corporation |
|---|---|
| Registered facility | Beekley Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Imaging artifact can occur on mammogram result |
| Product | Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate. |
| Quantity | 86,000 units |
| Distribution | International Distribution including Nationwide(USA), and the countries of Japan and Canada. |
| Initiated | 2012-07-02 |
| Classified | 2012-07-26 |
| Terminated | 2013-07-09 |
| Recall number | Z-2080-2012 |
| 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-2080-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62432/
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