Z-2239-2026Class II

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

Name: Z-2239-2026 HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Creator: Devicor Medical Products Inc
Published: 2026-04-24
License: https://open.fda.gov/license/

Devicor Medical Products Inc / initiated 2026-04-24 / Open, Classified / root cause: labeling and UDI

FDA source

Devicor Medical Products Inc began a recall of HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 on 2026-04-24. FDA classified it as Class II and gives the reason as "Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2239-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-24
Posted: 2026-05-27
Recalling firm: Devicor Medical Products Inc
Product: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An URGENT FIELD SAFETY RECALL was sent to customers beginning 4/24/26. Action to be taken by the user: As a result of this notification, please conduct the following: "Examine your inventory and identify any devices from Lot F12607207D. "Immediately remove from use any devices labeled as 4010 02 15 T4 from this lot. "Contact your local sales representative to coordinate next steps. The affected product (devices labeled as4010 02 15 T4 from lot F12607207D) may either: -Be handed to a sales representative for removal, or -Be disposed of at your facility in accordance with local and institutional disposal requirements. "If a marker from this lot has already been implanted, review and update patient records as appropriate. "Complete and return the Recall Response Form (included with this notification), even if you no longer have affected product, to confirm the receipt of this notice and completion of required actions. If you have any additional questions, comments or concerns please contact our Customer Support at +1 877-926-2666. You may also email [email protected].
Quantity in commerce: 1910 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Product codes and lots: Lot Number: F12607207D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2239-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2239-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-27

Product code NEU

K212158Class IIHydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. / cleared 2022-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)