HydroMARK Breast Biopsy Marker (Devicor) – label mismatch (2022)
Small patient label mismatch can cause potential confusion about product identification.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Brand
Devicor Medical Products Inc
Lot Codes / Batch Numbers
UDI-DI: 00841911102472 Lot F12201281D
Products Sold
UDI-DI: 00841911102472 Lot F12201281D
Devicor Medical Products Inc is recalling HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 due to 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 sma. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 mmtchnrecall@mammotome.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026