Integra LifeSciences Corp. (NeuroSciences): Device Recall

Recall Details

Recall Number

Z-1959-2025

Classification

Class I

Product Type

Device

Recalling Firm

Integra LifeSciences Corp. (NeuroSciences)

Status

Ongoing

Date Initiated

05/22/2025

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2,524 units

Reason for Recall

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

Product Description

Extended Tip Applicator, 15 CM, Box of 5.

Distribution Pattern

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.

Other Recalls by Integra LifeSciences Corp. (NeuroSciences)

• Class II: Risk 12/12/2025
  Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
• Class II: Risk 12/12/2025
  Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
• Class II: Risk 10/03/2025
  It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
• Class I: Dangerous 09/26/2025
  Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
• Class I: Dangerous 09/26/2025
  Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

View all recalls by Integra LifeSciences Corp. (NeuroSciences) →