BiomarC EX Fiducial Marker System — Class III medical device recall Z-3161-2024
Ongoing recall by Carbon Medical Technologies, Inc., reported 2024-09-25, distributed nationwide. This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient
| Recall number | Z-3161-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carbon Medical Technologies, Inc., Saint Paul, MN, United States |
| Recall initiated | 2024-07-26 |
| Classified | 2024-09-17 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00850002461305 |
| Lot numbers | 2112355B |
| Model numbers | 040165 |
Product
BiomarC EX Fiducial Marker System, Catalog Number 040165
Reason for recall
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3161-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.