Z-2309-2017Class III

Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Name: Z-2309-2017 Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Creator: Beekley Corporation
Published: 2017-05-08
License: https://open.fda.gov/license/

Beekley Corporation / initiated 2017-05-08 / Terminated / root cause: manufacturing process

FDA source

Beekley Corporation began a recall of Beekley Medical 0-SPOT Mammography Skin Markers REF 652 on 2017-05-08. FDA classified it as Class III and gives the reason as "Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels". 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-2309-2017
Classification: Class III
Status: Terminated
Initiated: 2017-05-08
Posted: 2017-06-27
Terminated: 2017-06-20
Recalling firm: Beekley Corporation
Product: Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Product code: JAC System, X-Ray, Film Marking, Radiographic
Reason for recall: Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434.
Quantity in commerce: 104 boxes (58/box)= 6,032 total units
Distribution: US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
Product codes and lots: LOT 652.04251701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2309-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2309-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07

Product code JAC

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)