Beekley TomoSPOT Mammography Skin Markers Recalled for Imaging Artifacts
Beekley Corporation is recalling TomoSPOT skin markers used in mammography because they may create imaging artifacts that mimic calcifications on patient mammograms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (misdiagnosis due to imaging artifacts) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beekley Corporation is recalling specific lots of TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785, and 785S skin markers. These products are designed to adhere to the skin to mark and identify moles during mammography procedures. The recall involves 3,384,024 pieces in total.
The recall is being conducted because there is a potential for the markers to create imaging artifacts that can mimic calcifications on a patient's mammogram. This could potentially interfere with the interpretation of the imaging results. The affected products were distributed worldwide, including in the United States, Australia, Austria, Bahrain, Canada, Great Britain, Israel, Saudi Arabia, South Africa, and the United Arab Emirates.
Healthcare providers and consumers should stop using the affected lots of TomoSPOT markers. Specific lot numbers for each reference number are listed in the official recall documentation. Users should contact Beekley Corporation for further instructions on how to handle the recalled products.
The recalled product
- Product
- TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
- Manufacturer
- Beekley Corporation
- Affected units
- 3,384,024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Beekley Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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