RegWardenFDA facility compliance records
Company

Medistim ASA

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2025: 1 recalls120172018201920202021202220232024120252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-09-26
    Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
  • Class IITerminated2017-04-25
    A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

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. “Medistim ASA — 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-9038441-medistim-asa/

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