Mammotome HydroMARK recallZ-1124-2022 · Devicor Medical Products Inc · initiated Mar 30, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Devicor Medical Products Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
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].
Recall details
- Recall number
- Z-1124-2022
- Status
- Terminated
- Initiated by the company
- Mar 30, 2022
- Recalling firm
- Devicor Medical Products Inc
- Quantity
- 90 devices
- Product code
- NEU
- FDA submissions
- K210752
- Distribution
- US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Product description
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Code information (models, lots, serial numbers)
UDI-DI: 00841911102472 Lot F12201281D
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Mammotome HydroMARK CA000515003Devicor Medical Products, Inc. · Marker, Radiographic, Implantable1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page