RegWardenFDA facility compliance records
Company

Mint Medical GmbH

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

Recalls by year

FDA actions on record by year2024: 1 recalls; 2026: 1 recalls201720182019202020212022202312024202512026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-01-07
    If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
  • Class IIOngoing2024-11-15
    Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

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. “Mint Medical GmbH — 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-10049287-mint-medical-gmbh/

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