Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction
Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speakers may malfunction.
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, and the hazard involves a malfunctioning speaker which is a functional defect rather than a direct physical injury risk, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Integra LifeSciences Corporation is recalling the Camino ICP Monitor (CAM 02) and Licox PtO2 Monitor (LCX02 & LCX02R). The recall is being conducted due to complaints that the audible speaker on these devices malfunctions.
The affected devices are compact, portable monitors used with specific transducer-tipped catheters to measure and display oxygen partial pressure and temperature in brain tissue. The recall covers 273 monitors distributed worldwide.
Consumers and healthcare providers should stop using the affected monitors and contact Integra LifeSciences Corporation for further instructions on the recall.
The recalled product
- Product
- The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 273
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)
- All Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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