BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BiomarC EX Fiducial Marker System, Catalog Number 040165
Brand
Carbon Medical Technologies, Inc.
Lot Codes / Batch Numbers
UDI/DI 00850002461305, Lot Number 2112355B
Products Sold
UDI/DI 00850002461305, Lot Number 2112355B
Carbon Medical Technologies, Inc. is recalling BiomarC EX Fiducial Marker System, Catalog Number 040165 due to This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Recommended Action
Per FDA guidance
Carbon Medical Technologies issued an IMPORTANT" MEDICAL DEVICE RECALL notice to its sole consignee on 07/26/2024 via USPS certified mail and email. The notice explained the issue, the potential risk to the patient, and requested the the return of the affected product. Distributors were directed to notify their customers and to provide them with a copy of the MRI insert to be distributed to the patients.
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