Integra Neuro Sciences LICOX temperature probe, Model C8.B Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LICOX temperature probe, Model C8.B
Brand
Integra Neuro Sciences
Lot Codes / Batch Numbers
Lot numbers: 160504 and 240604
Products Sold
Lot numbers: 160504 and 240604
Integra Neuro Sciences is recalling LICOX temperature probe, Model C8.B due to LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 en. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
Recommended Action
Per FDA guidance
LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
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 noticeDistribution
As reported by FDA
CA, CO, DE, FL, GA, IL, IN, LA, MD, MA, MI, MN, MT, NE, NY, NC, OH, OR, PA, SD, TN, TX, VA, DC
Page updated: Jan 10, 2026