Solstice Xact Mole Markers Recalled for Detaching Radiopaque Material
Solstice Corporation is recalling 736 Xact mole markers for mammography because the radiopaque material may detach, causing imaging artifacts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II because the detached radiopaque material may cause temporary or medically reversible adverse health consequences, such as imaging artifacts. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Solstice Corporation is recalling 736 units of the Xact mole marker for mammography, Model/Catalog Number M15RM. The recall is due to a defect where the radiopaque material may detach from the marker. In some cases, imaging artifacts were noted and attributed to this detached material.
The affected units were distributed nationwide in the United States, specifically in California, Florida, Illinois, Indiana, Minnesota, Missouri, New York, Ohio, Pennsylvania, Texas, West Virginia, and Puerto Rico, as well as in Canada. The specific lot number is M15RM26A.
Consumers and healthcare providers should stop using these markers and contact Solstice Corporation for further instructions or a replacement.
The recalled product
- Product
- Xact mole marker for mammography Model/Catalog Number: M15RM
- Manufacturer
- Solstice Corporation
- Affected units
- 736
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 (4)
- part #: M15RM
- UDI-DI: 00854623006068
- UPC-A
- lot #: M15RM26A
Distribution
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