Beekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts
Beekley Corporation is recalling O-SPOT REF 791 and 791S skin 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. The hazard involves potential misdiagnosis due to imaging artifacts, which is a significant risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beekley Corporation is recalling O-SPOT REF 791 and 791S, which are skin markers used to identify moles during mammography. The recall involves 3,384,024 pieces distributed nationwide in the US and in several international countries including Australia, Austria, Bahrain, Canada, Great Britain, Israel, Saudi Arabia, South Africa, and the United Arab Emirates.
The recall was initiated because there is a potential for the markers to create imaging artifacts that may mimic calcifications on patient mammograms. This could lead to misinterpretation of the imaging results. Specific lot numbers for both REF 791 and REF 791S are listed in the official recall documentation.
Healthcare facilities and consumers should stop using these specific markers and contact Beekley Corporation for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- O-SPOT REF 791, 791S 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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