The Recall Desk
HighFDA (Devices)·Z-2239-2026·Announced 2026-06-03

HydroMARK breast biopsy markers may carry the wrong inner labeling

HydroMARK Breast Biopsy Site Markers are being recalled because boxes labeled as T3 markers may contain individual packages labeled as T4 markers. 1,910 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where mismatched inner labeling could lead to the wrong marker being placed during a biopsy, a risk of harm with no injuries reported.

Plain-English summary

The HydroMARK Breast Biopsy Site Marker, model number 4010-02-15-T3, lot F12607207D, is being recalled. The action covers 1,910 units.

The stated reason is incorrect inner package labeling: boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 markers. The FDA classified the action as Class II.

Distribution was worldwide, covering the United States nationwide and Canada and Singapore. The markers are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the model number and lot number above, quarantine it, and follow the instructions issued by the manufacturer.

The recalled product

Product
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Manufacturer
Devicor Medical Products Inc
Category
Medical Device — Biopsy site marker
Hazard
  • mislabeling
  • wrong-product
  • biopsy-marker
  • class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: F12607207D

Distribution

Distributed nationwide across the United States.

Related recalls

Same category