Z-1124-2022Class II

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

Name: Z-1124-2022 HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Creator: Devicor Medical Products Inc
Published: 2022-03-30
License: https://open.fda.gov/license/

Devicor Medical Products Inc / initiated 2022-03-30 / Terminated / root cause: labeling and UDI

FDA source

Devicor Medical Products Inc began a recall of HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 on 2022-03-30. FDA classified it as Class II and gives the reason as "Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1124-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-30
Posted: 2022-05-23
Terminated: 2024-04-30
Recalling firm: Devicor Medical Products Inc
Product: HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On March 30, 2022, the firm distributed Urgent Medical Device Recall letters to their customers via email. Customers were informed of the labeling issue. Users were instructed to examine their inventory and identify any affected product. Users should contact their local sales representative for correction of any affected devices. The sales representative will be on site to remove the affected patient labels. Please do not use affected patient labels from this lot. If you have any additional questions, comments or concerns please contact the firm's Customer Support at +1 877-926-2666. You may also email [email protected].
Quantity in commerce: 90 devices
Distribution: US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Product codes and lots: UDI-DI: 00841911102472 Lot F12201281D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1124-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1124-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-23

Product code NEU

K210752Class IIHydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. / cleared 2021-04-14

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)