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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Manufacturer
- Beekley Corporation
- Category
- Medical Device — Diagnostics
- Hazard
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
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Similar recalls
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- HighBeekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts
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