Z-2830-2018Class II

O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography

Name: Z-2830-2018 O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography
Creator: Beekley Corporation
Published: 2018-06-13
License: https://open.fda.gov/license/

Beekley Corporation / initiated 2018-06-13 / Terminated / root cause: manufacturing process

FDA source

Beekley Corporation began a recall of O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography on 2018-06-13. FDA classified it as Class II and gives the reason as "There is a potential for imaging artifact to mimic calcifications on patient's mammograms". 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-2830-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-13
Posted: 2018-08-16
Terminated: 2018-11-13
Recalling firm: Beekley Corporation
Product: O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Product code: JAC System, X-Ray, Film Marking, Radiographic
Reason for recall: There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 14, 2018, Beekley Medical issued an "URGENT MEDICAL DEVICE RECALL" notice dated June 13, 2018 to customers. The notice described the products, problem and actions to be taken. Customers are advised to do the following: - Inspect stock and quarantine affected product - complete and return the acknowledgement response form via fax to: 1-800-735-1234 or mail. - contact firm if inventory of affected product remains with customers at 1-800-233-5539 between 8:00am - 5:30pm EDT. If you have any issues occurred or for further question, contact Quality Assurance & Regulatory Manager at 1-800-233-5539x434.
Quantity in commerce: 3,384,024 pieces in total.
Distribution: Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
Product codes and lots: REF 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271801 05291802 03081801 03091801 05111801 05251801 04091801 02201801 02231801 02071801 02091801 03161802 03231801 02131801 05031801 03011801 03291801 04301801 05171801 04161801 04261801 02051801 04051801 03201801 03221801 02151801 03221802 02021801 05231802 05021801 04191802 05291801 04301802 05211802 02191802 REF 791S - Lot Numbers: 03191801 02221802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2830-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2830-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2831-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16
Z-2832-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16

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)