Extended Tip Applicator 8CM recall: Endotoxin
Extended Tip Applicator 8CM, Box of 1.
Why was Extended Tip Applicator 8CM recalled?
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: 201108; UDI 10381780000167; All Lots.
- Product
- Extended Tip Applicator 8CM, Box of 1.
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 212 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.
- Recall date
- July 2, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)