Z-2080-2012Class II

Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm

Name: Z-2080-2012 Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm
Creator: Beekley Corporation
Published: 2012-07-02
License: https://open.fda.gov/license/

Beekley Corporation / initiated 2012-07-02 / Terminated / root cause: manufacturing process

FDA source

Beekley Corporation began a recall of 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... on 2012-07-02. FDA classified it as Class II and gives the reason as "Imaging artifact can occur on mammogram result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2080-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2015-06-26
Terminated: 2013-07-09
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.
Product code: IZH System, X-Ray, Mammographic
Reason for recall: Imaging artifact can occur on mammogram result
Root cause tag: manufacturing process
FDA 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 in commerce: 86,000 units
Distribution: International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Product codes and lots: Lot Numbers: 107657, 108150, 108833

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2080-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2080-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

Product code IZH

K073262Class IIBellaBeekley Corp. / cleared 2008-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)