The Recall Desk
LowFDA (Devices)·Z-2309-2017·Announced 2017-06-14

Beekley Medical Mammography Skin Markers Recalled for Mislabeling

Beekley Corporation is recalling 0-SPOT Mammography Skin Markers because they were mislabeled with A-SPOT labels. The recall affects 6,032 units distributed in the US and Canada.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling error without reported injuries.

Plain-English summary

Beekley Corporation is recalling Beekley Medical 0-SPOT Mammography Skin Markers (REF 652) because the product was mislabeled with A-SPOT (REF 651) labels. The recall involves 104 boxes, totaling 6,032 units, identified by LOT 652.04251701.

The affected products were distributed in the United States to the states of Arkansas, California, Georgia, Illinois, Texas, Minnesota, Nevada, New York, and Wisconsin, as well as internationally to Canada. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Healthcare providers and consumers who have these specific skin markers should stop using them and contact Beekley Corporation for instructions on return or replacement.

The recalled product

Product
Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT 652.04251701

Distribution

Distributed in 9 states: