Facility

Mermaid Medical A/S (FL Site)

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

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3027260597
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	8033 Cooper Creek Blvd Ste 106 University Park, FL, US 34201
Registration status	Active · expires 2026
Parent company	Mermaid Medical (owner-operator 10045264)
Brand names	M-Biopsy

Activity by year

Recalls (2)

Devices registered here (1)

Instrument, Biopsy
Product code KNW (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1075

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Mermaid Medical A/S (FL Site) (FEI 3027260597) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027260597-mermaid-medical-a-s-fl-site/

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