The Recall Desk

Manufacturer

Galil Medical, Inc.

2 recalls in our database name Galil Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-11-20

Of the 2 recalls from Galil Medical, Inc. 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-0404-2020·2019-11-20

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging

    Galil Medical is recalling 49 Visual-ICE Cryoablation Systems because the needles may clog or fail to freeze tissue adequately.

    Product
    Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-2261-2012·2012-08-29

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Gas Regulator Failure

    Galil Medical is recalling Visual-ICE Cryoablation Systems because gas regulators may fail, rendering the devices inoperable.

    Product
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these pr
    Category
    Medical Device
    Distribution
    Distributed nationwide