Public recall detail

HydroMARK™ Breast Biopsy Site Marker

2026-05-01

medium
General and plastic surgery Labelling and packaging
Quick summary

Quick summary: HydroMARK™ Breast Biopsy Site Marker. Reason: Labelling and packaging. Category: General and plastic surgery. Date: 2026-05-01.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: HydroMARK™ Breast Biopsy Site Marker. Reason: Labelling and packaging. Category: General and plastic surgery. Date: 2026-05-01.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDevicor Medical Products, Inc.
ProductHydroMARK™ Breast Biopsy Site Marker
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-82023

Affected products

ProductHydroMARK™ Breast Biopsy Site Marker
LotF12607207D
Model4010-02-15-T3
Serial numberF12607207D
DescriptionHydroMARK™ Breast Biopsy Site Marker

Issue

Devicor Medical Products, Inc. is initiating a voluntary medical device recall for certain HydroMARK™ Breast Biopsy site markers due to incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. Users should immediately remove from use any devices labeled as 4010-02-15-T4 from lot F12607207D.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesDevicor Medical Products, Inc. 300 E-Business Way, Cincinnati, Ohio, United States, 45241
Recall date2026-04-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82023
Background{}
CompaniesDevicor Medical Products, Inc. 300 E-Business Way, Cincinnati, Ohio, United States, 45241
AudiencesHealthcare
Source updated2026-05-01

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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