Saint Paul, MN, United States
Carbon Medical Technologies, Inc. recalls
2 recalls recorded since 2018, most recently on 26 July 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 26 July 2024
- Reason
- This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
- Distribution
- US Nationwide distribution in the state of TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3161-2024
- BiomarC EX Fiducial Marker System, Catalog Number 040165
Terminated Class II Medical devices
- Recall started
- 16 December 2022
- Terminated
- 9 August 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of OHIO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1041-2023
- Mammotome MammoStar Biopsy Site Identified, REF STAR1401
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.