RegWardenFDA facility compliance records
Company

Carbon Medical Technologies, Inc.

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2022: 1 recalls; 2024: 1 recalls201720182019202020211202220231202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIIOngoing2024-07-26
    This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
  • Class IITerminated2022-12-16
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Carbon Medical Technologies, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9034784-carbon-medical-technologies-inc/

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