HydroMARK Breast Biopsy Site Marker recall: Labeling Error
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Why was HydroMARK Breast Biopsy Site Marker recalled?
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: F12607207D
- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Recalling firm
- Devicor Medical Products Inc
- Quantity
- 1910 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
- Recall date
- June 3, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)