HIGHFDA DEVICE

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 24, 2026
Status
ACTIVE

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    April 24, 2026

  2. Reported by FDA DEVICE

    June 3, 2026

  3. RecallRadar source check

    June 10, 2026

  4. 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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot Number: F12607207D
Affected States
ALL
Report Date
June 3, 2026
Recall Status
ACTIVE