Z-2111-2012Class II

Beekley O-Spots Floral Skin Markers -Order Number: 752

Name: Z-2111-2012 Beekley O-Spots Floral Skin Markers -Order Number: 752
Creator: Beekley Corporation
Published: 2012-07-09
License: https://open.fda.gov/license/

Beekley Corporation / initiated 2012-07-09 / Terminated

FDA source

Beekley Corporation began a recall of Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern on 2012-07-09. FDA classified it as Class II and gives the reason as "Digital Skin Mammography Marker separating from the backing of the spot material". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2111-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-09
Posted: 2012-07-31
Terminated: 2013-07-09
Recalling firm: Beekley Corporation
Product: Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Product code: JAC System, X-Ray, Film Marking, Radiographic
Reason for recall: Digital Skin Mammography Marker separating from the backing of the spot material
FDA root cause: Unknown/Undetermined by firm
Action: Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form.
Quantity in commerce: 267,332 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2111-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-30
Z-2110-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-30
Z-2111-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-30
Z-2112-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-30

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)