Extended Tip Applicator, 8CM, Box of 5.
FDA Recall #Z-1958-2025 — Class I — May 22, 2025
Product Description
Extended Tip Applicator, 8CM, Box of 5.
Reason for Recall
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
6,216 units
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.
Code Information
Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated