# FDA recall Z-2650-2023

> **Icecure Medical Ltd** · Class II · device recall initiated 2019-09-16.

## 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)

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2650-2023
- **Recalling firm:** Icecure Medical Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-16
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caesarea, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2650-2023

## Citation

> AI Analytics. FDA recall Z-2650-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2650-2023. Source: US FDA. Licensed CC0.

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