Breast Biopsy Site Markers Recalled for Incorrect Inner Package Labeling
Devicor Medical Products Inc is recalling 1,910 units of HydroMARK Breast Biopsy Site Markers (Model 4010-02-15-T3) due to inner packaging labeled as T4 instead of T3, creating a mismatch between outer box and inner package labels.
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 an FDA Class II recall involving a labeling and packaging discrepancy with no reported illnesses, injuries, or safety incidents. Per the rubric, minor labeling errors without reported harm are classified as Moderate.
Plain-English summary
Devicor Medical Products Inc is recalling 1,910 units of HydroMARK Breast Biopsy Site Markers, Model Number 4010-02-15-T3 (Lot Number F12607207D). The product is a medical device used to mark biopsy sites during breast procedures.
The recall is due to incorrect inner package labeling. Boxes labeled as 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers, creating a mismatch between the outer box labeling and the actual contents inside.
The affected product was distributed worldwide, including to customers in the United States, Canada, and Singapore. Healthcare facilities that received this product should verify the lot number and contact the manufacturer for proper replacement or corrective instructions.
The recalled product
- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Manufacturer
- Devicor Medical Products Inc
- Hazard
- labeling-error
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 (1)
- Lot Number: F12607207D
Distribution
Distributed nationwide across the United States.
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