Integra LifeSciences Corp. (NeuroSciences): Medical Device Recall in 2025 - (Recall #: Z-1958-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Extended Tip Applicator, 8CM, Box of 5.

Product Classification:

Class I

Date Initiated: May 22, 2025

Date Posted: July 2, 2025

Recall Number: Z-1958-2025

Event ID: 96934

Reason for Recall:

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

Status: Ongoing

Product Quantity: 6,216 units

Code Information:

Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.

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.

Voluntary or Mandated:

Voluntary: Firm initiated