The Recall Desk

Manufacturer

Icecure Medical Ltd

1 recall in our database name Icecure Medical Ltd as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2023-10-11

Of the 1 recalls from Icecure Medical Ltd 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.

1–1 of 1

  • HighFDA (Devices)·Z-2650-2023·2023-10-11

    IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety

    Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.

    Product
    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
    Category
    Medical Device
    Distribution
    Distributed nationwide