The Recall Desk

Manufacturer

Galemed Corporation

3 recalls in our database name Galemed Corporation as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
1
Severe
1
Most recent
2020-01-01

Of the 3 recalls from Galemed Corporation we have scored against our rubric, 1 (33%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) 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.

1–3 of 3

  • CriticalFDA (Devices)·Z-0022-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0021-2020·2020-01-01

    Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect

    Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.

    Product
    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0020-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed Corporation is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
    Category
    Medical Device
    Distribution
    2 states