FDA Device Recall Z-1958-2025
Integra LifeSciences Corp. (NeuroSciences) · Princeton, NJ
Class I — life-threatening Ongoing
Device
Extended Tip Applicator, 8CM, Box of 5.
Reason for recall
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Recall record
- Recall number
Z-1958-2025- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.
- Recall initiated
- 2025-05-22
- Classified by FDA Center
- 2025-06-20
- FDA published
- 2025-07-02
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Firm location
- Princeton, NJ
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.