Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by I Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by I
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
CC1 Licox¿ PO2 Microprobe, 200 mm 021213, 040414, 070314, 130114, 240214, 270114, 280314, 300614 CC12 Licox¿ PO2 Microprobe, 300 mm 020614, 040814, 050514, 070414, 070714, 220414 CC1.P1 Licox¿ PMO Combined Probe Containing Oxygen and Temperature 050614, 060214, 060314, 100414, 100714, 130214, 130314, 170114, 190614, 210814, 260614, 310714 IM3ST Licox¿ Complete Brain IMC-Probe Kit: 020614, 030314, 110714, 130114, 140314, 160614, 180714, 200114, 280314 IP1.P Licox¿ Single Lumen Bolt CMPS and Temperature Bolt Kit 030714, 060214, 060314, 070814, 080514, 100714, 120614, 130314, 190614, 310714 IP2.P Licox¿ Double Lumen Bolt CMPS, Temperature and ICP Monitoring Kit 030714, 050614, 060214, 060314, 070814, 080514, 090114, 100714, 130314, 140814, 200214, 200414, 260614, 290814 IT2 Licox¿ Tunneling CMPS and Temperature Monitoring Kit 090114, 100414, 190614, 200214, 260614, 310714
Products Sold
CC1 Licox¿ PO2 Microprobe, 200 mm 021213, 040414, 070314, 130114, 240214, 270114, 280314, 300614 CC12 Licox¿ PO2 Microprobe, 300 mm 020614, 040814, 050514, 070414, 070714, 220414 CC1.P1 Licox¿ PMO Combined Probe Containing Oxygen and Temperature 050614, 060214, 060314, 100414, 100714, 130214, 130314, 170114, 190614, 210814, 260614, 310714 IM3ST Licox¿ Complete Brain IMC-Probe Kit: 020614, 030314, 110714, 130114, 140314, 160614, 180714, 200114, 280314 IP1.P Licox¿ Single Lumen Bolt CMPS and Temperature Bolt Kit 030714, 060214, 060314, 070814, 080514, 100714, 120614, 130314, 190614, 310714 IP2.P Licox¿ Double Lumen Bolt CMPS, Temperature and ICP Monitoring Kit 030714, 050614, 060214, 060314, 070814, 080514, 090114, 100714, 130314, 140814, 200214, 200414, 260614, 290814 IT2 Licox¿ Tunneling CMPS and Temperature Monitoring Kit 090114, 100414, 190614, 200214, 260614, 310714
Integra LifeSciences Corp. is recalling Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LIC due to Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was progr. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026