Summary
The FDA issued a Class I for Extended Tip Applicator, 8CM, Box of 5. by Integra LifeSciences Corp. (NeuroSciences). Reason: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance..
Details
Source
Device Recall
External ID
Z-1958-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
Product Description
Extended Tip Applicator, 8CM, Box of 5.
Lot/Code Info: Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.
Quantity Affected: 6,216 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-22
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp. (NeuroSciences)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. (NeuroSciences) have FDA actions?
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1958-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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