FDA Medical Device Recalls (openFDA)
Beekley Corporation: 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.
- Recall number
- Z-2080-2012
- Recalling firm
- Beekley Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-07-02
- Posted
- not on file
- Terminated
- 2013-07-09
- Reason
- Imaging artifact can occur on mammogram result
- Root cause
- Nonconforming Material/Component
- Action
- Beekley Medical issued "Urgent: Medical Device Recall" notifications dated June 29, 2012 that were sent via certified mail USPS on July 2, 2012. The product issue was was described and customers were provided the recommended actions. Customer Service number is 1-800-233-5539.
- Quantity
- 86,000 units
- Distribution
- International Distribution including Nationwide(USA), and the countries of Japan and Canada.
- Lot, serial or model codes
- Lot Numbers: 107657, 108150, 108833
- 510(k) numbers
- ["K073262"]
- PMA numbers
- not on file
- Product code
- IZH
- 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