RegWardenFDA facility compliance records
Company

Mermaid Medical

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2024: 1 recalls12015201620172018201920202021202220231202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2024-05-01
    Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
  • Class IITerminated2015-06-15
    Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.

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. “Mermaid Medical — 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-10045264-mermaid-medical/

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