Integra Camino Intracranial Pressure Monitoring Catheters Recalled for Missing MR Safety Labeling
Integra Limited is recalling specific Camino Intracranial Pressure Monitoring Catheters and Kits because they lack required labeling indicating they are unsafe in MRI environments.
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. The hazard is a labeling deficiency regarding MRI safety, which is a theoretical risk of harm if the device is used in an MR environment, but no injuries or illnesses have been reported.
Plain-English summary
Integra Limited is recalling specific models of Camino Intracranial Pressure (ICP) Monitoring Catheters and Kits. The affected products include catalog numbers 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, and 110-4LC. These sterile transducer-tipped catheters are used by neurosurgeons to monitor intracranial pressure or pressure and temperature.
The recall was initiated after an internal evaluation determined that the products require additional labeling to comply with US FDA requirements. Specifically, the devices must indicate that they are UNSAFE in an MR (Magnetic Resonance) environment. The source text does not report any illnesses, injuries, or deaths associated with this labeling deficiency.
The recall covers 79,887 units distributed nationwide. Healthcare facilities and users should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice to ensure compliance with safety labeling requirements.
The recalled product
- Product
- Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that…
- Manufacturer
- Integra Limited
- Hazard
- Affected units
- 79,887
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 (20)
- Product / Catalogue No.s: 110-4B
- 110-4BC
- 110-4G
- 110-4H
- 110-4HC
- 110-4L
- 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484
- 3050RX198473
- 305000205426
- 3050RX197641
- 3050RX201421
- 305000205648
- 305000205652
- 3050RX199149
- 3050RX201407
- 3050RX199850
- 305000205976
- 3050RY189979
- 3050RX200862
- 305000206178
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Integra Limited
See all →- ModerateIntegra Flowable Wound Matrix Recalled for Stability Failure
FDA (Devices) · 2019-05-22
- ModerateIntegra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
FDA (Devices) · 2019-04-17
- ModerateIntegra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
FDA (Devices) · 2019-04-17
- ModerateIntegra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
FDA (Devices) · 2019-04-17
- HighIntegra Leyla Ball Joint Clamp Recalled for Potential Instability
FDA (Devices) · 2013-09-04
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateIntegra Recalls Camino ICP Catheters for MRI Safety Labeling
FDA (Devices) · 2014-07-23
- HighIntegra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error
FDA (Devices) · 2015-06-24
- ModerateIntegra Recalls Camino ICP Monitors Due to Speaker Malfunction
FDA (Devices) · 2015-05-27
- HighIntegra Camino Advanced Monitor Recalled for Reversed Pressure Display
FDA (Devices) · 2014-01-08
- SevereCereLink ICP Monitor recalled for out-of-range pressure readings
FDA (Devices) · 2022-08-03
- ModerateIntegra Recalls Camino and Licox Monitors Due to Speaker Malfunction
FDA (Devices) · 2015-05-27