Beekley S-SPOT REF 777 Mammography Markers Recalled for Imaging Artifacts
Beekley Corporation is recalling S-SPOT REF 777 and 777S markers because they may create imaging artifacts that mimic calcifications on 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 S-SPOT REF 777 and 777S markers. These products are designed to adhere to the skin for marking and identifying moles during mammography. The recall involves a total of 3,384,024 pieces.
The recall is being conducted because there is a potential for the markers to create imaging artifacts that may mimic calcifications on a patient's mammograms. This could potentially interfere with the accuracy of the imaging results.
The affected products were distributed worldwide, including in the United States (nationwide), Australia, Austria, Bahrain, Canada, Great Britain, Israel, Saudi Arabia, South Africa, and the United Arab Emirates. Specific lot numbers for REF 777 include 02281802, 05301801, 04041801, 04211801, 03301801, 05101802, 05241801, 02191801, 03151801, 03281801, 04281801, and 02131802. The source text does not specify lot numbers for the REF 777S variant.
Healthcare providers and consumers should stop using these specific markers and contact Beekley Corporation for further instructions on how to proceed.
The recalled product
- Product
- S-SPOT REF 777, 777S 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.
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