Biopsy marker device recalled for label and contents mismatch
Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.
What this means for you
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: This is a voluntary, precautionary FDA Class II recall based on a labeling mismatch with no reported injuries or adverse events. The hazard is theoretical and precautionary in nature.
Plain-English summary
Carbon Medical Technologies, Inc. is recalling 550 Mammotome MammoStar Biopsy Site Identified medical devices (Lot 2201011A, UDI 00858015005431, Model STAR1401). The devices were distributed nationwide in Ohio. The labeling incorrectly identifies the product as a STAR1401 1x3mm Barbell-shaped marker preloaded in a 14-gauge needle, while the packaging actually contains STAR1402 1x5mm Tribell-shaped markers.
The mismatch between the label and the actual product contents means that healthcare providers could unknowingly use a different marker size and shape than specified if they rely solely on the package label. There is a risk of using the incorrect product during biopsy procedures.
This is a Class II recall by the FDA. No injuries or adverse events related to this labeling mismatch have been reported to date.
The recalled product
- Product
- Mammotome MammoStar Biopsy Site Identified, REF STAR1401
- Manufacturer
- Carbon Medical Technologies, Inc.
- Category
- Medical Device — Biopsy Markers
- Hazard
- labeling-mismatch
- product-mismatch
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 (2)
- UDI/DI 00858015005431
- Lot Number 2201011A
Distribution
Distributed nationwide across the United States.
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