Integra LifeSciences Corp. (NeuroSciences) medical device recall: Extended Tip Applicator
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96934
- Recall initiated
- May 22, 2025
- Classified by FDA
- Jun 20, 2025
- Posted in Enforcement Report
- Jul 2, 2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Firm location
- Princeton, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 22, 2025. FDA classified it 29 days later, on Jun 20, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: 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,… Integra LifeSciences Corp. (NeuroSciences) has 13 recalls in our records.
Recalled products (3)
Z-1958-2025 Class I Ongoing
Extended Tip Applicator, 8CM, Box of 5.
Codes / lots: Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.
Quantity: 6,216 units
Z-1959-2025 Class I Ongoing
Extended Tip Applicator, 15 CM, Box of 5.
Codes / lots: Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.
Quantity: 2,524 units
Z-1960-2025 Class I Ongoing
Extended Tip Applicator 8CM, Box of 1.
Codes / lots: Model/Catalog Number: 201108; UDI 10381780000167; All Lots.
Quantity: 212 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96934
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.