Medical Device Recall: Extended Tip Applicator, 8CM, Box of 5.
Integra LifeSciences Corp. (NeuroSciences) · May 22, 2025
Reason for Recall
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
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.
States Affected
NATIONWIDE
Quantity Affected
6,216 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1958-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.