Quick Facts at a Glance
- Recall Date
- April 24, 2026
- Hazard Level
- HIGH
- Brand
- Devicor Medical Products
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Devicor Medical Products
- Model numbers
- Lot Number: F12607207D
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 24, 2026
Reported by FDA DEVICE
June 3, 2026
RecallRadar source check
June 10, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Devicor Medical Products Inc or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Quantity: 1910 units. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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