Extended Tip Applicator, 8CM, Box of 5.
Reported: July 2, 2025 Initiated: May 22, 2025 #Z-1958-2025
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.
Details
- Recalling Firm
- Integra LifeSciences Corp. (NeuroSciences)
- Units Affected
- 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.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Extended Tip Applicator, 8CM, Box of 5.. Recalled by Integra LifeSciences Corp. (NeuroSciences). Units affected: 6,216 units.
Why was this product recalled? ▼
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2025. Severity: Critical. Recall number: Z-1958-2025.
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