Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator 8CM

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Extended Tip Applicator 8CM, Box of 1.

An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification dated 5/22/25 was mailed to consignees for this product removal. Consignees are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. The provided notification is to be forwarded to users of affected devices and a copy retained for consignee records. A Return Material Authorization number will be generated upon receipt of the Acknowledgment Form for credit. Sales Representatives and Distributors are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. Distributors who further distributed affected devices are to forward the provided notification to their customers and collect Acknowledgement forms on their behalf to submit to Integra. Sales Representatives will be contacted by Post Market Quality to coordinate return of devices. Consignees with any questions are to contact Customer Service by phone at 1-800-654-2873 or by email at custsvcnj@integralife.com. Additional communications were made to customers on 7/10/25 and 7/18/25 informing them that expired devices are also subject to this recall and should be disposed of.

• FDA enforcement recordOfficial FDA database entry for Z-1960-2025
• FDA 510(k) clearance · K091315The device's official FDA premarket clearance record
• FDA device classification · FMFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.