Integra Recalls Camino ICP Monitors Due to Speaker Malfunction
Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.
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 functional malfunction (speaker) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity recall.
Plain-English summary
Integra LifeSciences Corporation is recalling the Integra Camino ICP Monitor (CAM02) and Licox PtO2 Monitor (LCX02 & LCX02R). The recall is being conducted due to complaints that the audible speaker on the devices malfunctions.
The affected products are compact, portable devices used to measure and display intracranial pressure and intracranial temperature. A total of 1,482 monitors are involved in this recall, and the units were distributed worldwide. All lots are affected.
Healthcare facilities and users should stop using the affected monitors and contact Integra LifeSciences for further instructions on how to proceed with the recall.
The recalled product
- Product
- The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 1,482
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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