Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker
- Recalling company
- Devicor Medical Products Inc
- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Reason
- Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 24, 2026
- Reported
- Jun 3, 2026
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
- Status
- Ongoing
- Quantity
- 1910 units
- Lot / codes
- Lot Number: F12607207D
- Company location
- Cincinnati, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2239-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2239-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.