← FDA ENFORCEMENT
Z-2239-2026Class II

Devicor Medical Products Inc

Recalling firm
Devicor Medical Products Inc
Product type
Device
Status
Ongoing
Report date
2026-06-03
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Firm state
OH
Product quantity
1910 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

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

Code / lot info

Lot Number: F12607207D

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIFayus Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.
See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.