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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect results in the device being inoperable rather than causing direct physical injury or death, fitting the criteria for a moderate severity issue involving a functional failure without reported harm.
Plain-English summary
Galil Medical, Inc. is recalling four units of the Visual-ICE Cryoablation System, Model FPRCH 6000. The recall is due to a defect where the gas regulators may fail to regulate gas pressure, which renders the devices inoperable.
The affected devices are identified by the codes VL0004, VL0014, VL0015, and VL0016. These systems were distributed worldwide, including nationwide in the United States (specifically mentioning Minnesota) and in the United Kingdom and the Netherlands. The Visual-ICE System is intended for cryoablative destruction of tissue during minimally invasive procedures in various medical fields, including general surgery, dermatology, and oncology.
Healthcare providers and users of these devices should stop using the affected units and contact Galil Medical for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- Galil Medical, Inc.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- VL0004 VL0014 VL0015 VL0016
Distribution
Related recalls
Same manufacturer · Galil Medical, Inc.
See all →- HighGalil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging
FDA (Devices) · 2019-11-20
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighGalil Medical Recalls Visual-ICE Cryoablation Systems Due to Needle Clogging
FDA (Devices) · 2019-11-20
- HighBoston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls Prostate Cryoablation Kits Due to Needle Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IceForce 2.1 CX Cryoablation Needles
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IcePearl 2.1 CX Prostate Kit Due to Needle Deterioration
FDA (Devices) · 2020-07-29