Carbon Medical Technologies, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1041-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Product Classification:
Class II
Date Initiated: December 16, 2022
Date Posted: February 8, 2023
Recall Number: Z-1041-2023
Event ID: 91419
Reason for Recall:
The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.
Status: Terminated
Product Quantity: 550 devices
Code Information:
UDI/DI 00858015005431, Lot Number 2201011A
Distribution Pattern:
US Nationwide distribution in the state of OHIO.
Voluntary or Mandated:
Voluntary: Firm initiated