Z-1787-2014Class III

Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252

Name: Z-1787-2014 Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252
Creator: Beekley Corporation
Published: 2013-06-19
License: https://open.fda.gov/license/

Beekley Corporation / initiated 2013-06-19 / Terminated / root cause: labeling and UDI

FDA source

Beekley Corporation began a recall of Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography on 2013-06-19. FDA classified it as Class III and gives the reason as "Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1787-2014
Classification: Class III
Status: Terminated
Initiated: 2013-06-19
Posted: 2014-06-13
Terminated: 2014-06-16
Recalling firm: Beekley Corporation
Product: Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491
Quantity in commerce: 81 boxes
Distribution: Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
Product codes and lots: Lot Number: 252.04261301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1787-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1787-2014	Class III	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-12

Product code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)