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Integra LifeSciences Corp. (NeuroSciences) recalls Extended Tip Applicator 8CM, Box of 1.
Recalled July 2, 2025 · FDA recall Z-1960-2025 · Integra LifeSciences Corp. (NeuroSciences)
Hazard
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. · FDA Class I
Units
212 units
Sold at
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.
Description
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Product
Extended Tip Applicator 8CM, Box of 1.
Manufacturer(s)
Integra LifeSciences Corp. (NeuroSciences)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →