Beekley Corporation: Medical Device Recall in 2018 - (Recall #: Z-2830-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 13, 2018

Date Posted: August 22, 2018

Recall Number: Z-2830-2018

Event ID: 80558

Reason for Recall:

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

Status: Terminated

Product Quantity: 3,384,024 pieces in total.

Code Information:

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

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

Voluntary or Mandated:

Voluntary: Firm initiated