The FDA has posted 13 enforcement recalls from Integra LifeSciences Corp. (NeuroSciences) since 2025, none of them Class I (most serious). Most recent report: Jul 15, 2026.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the…
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Software issue that renders the touch screen unresponsive.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Firm name as filed with the FDA: “Integra LifeSciences Corp. (NeuroSciences)”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.