Icecure Medical Ltd: Medical Device Recall in 2023 - (Recall #: Z-2650-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: September 16, 2019

Date Posted: October 11, 2023

Recall Number: Z-2650-2023

Event ID: 92945

Reason for Recall:

Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

Status: Ongoing

Product Quantity: 16 units

Code Information:

UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated