RegWardenFDA facility compliance records
Facility

MINT MEDICAL GMBH

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

Activity by year

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

Devices registered here (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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MINT MEDICAL GMBH (FEI 3011706018) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011706018-mint-medical-gmbh/

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