The Recall Desk
LowFDA (Devices)·Z-1787-2014·Announced 2014-06-18

Beekley Spots Light Image O-Spots Recalled for Mislabeled Dispenser

Beekley Corporation is recalling 81 boxes of Light Image O-Spots for mammography because the dispensers were mislabeled as S-Spots.

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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a labeling error on the dispenser, which falls under the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Beekley Corporation is recalling 81 boxes of Light Image O-Spots for Mammography, Catalog Number 252. The product is used to identify raised moles during mammography procedures. The recall was initiated because the Light Image O-Spots Dispenser was mislabeled as Soft n' Stretchy Light Image S-Spots.

The affected product is identified by Lot Number 252.04261301. The recall covers a worldwide distribution, specifically within the United States in the states of California, Florida, Massachusetts, North Carolina, New York, and Pennsylvania.

Consumers and healthcare facilities should stop using the affected product and contact Beekley Corporation for further instructions or a refund.

The recalled product

Product
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
Affected units
81

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 Number: 252.04261301

Distribution

Distributed in 6 states: