The Recall Desk

Manufacturer

Mermaid Medical A/S

2 recalls in our database name Mermaid Medical A/S as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2024-07-03

Of the 2 recalls from Mermaid Medical A/S we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2213-2024·2024-07-03

    D*Clot® HD Rotational Thrombectomy System Recalled for Sterility Barrier Defect

    Mermaid Medical is recalling 190 D*Clot® HD Rotational Thrombectomy Systems worldwide due to failed sterility testing that indicates the sterility barrier may not be fully intact.

    Product
    The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2015·2015-07-29

    Mermaid Medical M-Biopsy Coaxial Introducer Needles Recalled for Plastic Debris

    Mermaid Medical A/S is recalling M-Biopsy Coaxial Introducer Needles due to the potential for small plastic pieces to be present in the luer of the cannula.

    Product
    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples
    Category
    Medical Device
    Distribution
    2 states