Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue Recalled by Icecure Medical Ltd Due to Updated User Manual DSR3200000 Rev. E to include...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Icecure Medical Ltd directly.
Affected Products
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)
Quantity: 16 units
Why Was This Recalled?
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Icecure Medical Ltd
Icecure Medical Ltd has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report