medical MODERATE Updated 2026-06-03

Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-1

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: F12607207D

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for HydroMARK Breast Biopsy Site →
View official government recall