Beekley Corporation: Medical Device Recall in 2018 - (Recall #: Z-2831-2018)

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:

S-SPOT REF 777, 777S 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-2831-2018

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 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers

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