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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Integra Extended Tip Applicators Recalled for Sterility Issues

Agency Publication Date: June 20, 2025
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Summary

Integra LifeSciences Corp. (NeuroSciences) is recalling approximately 8,952 Extended Tip Applicators because they may have potentially high levels of endotoxins and lack assurance of sterility. The recall includes 8CM and 15CM applicator models used during surgical procedures. While no injuries have been reported, using non-sterile medical equipment can lead to serious post-operative infections and other health complications.

Risk

Devices lacking sterility assurance or containing high endotoxin levels can cause serious infections, severe inflammation, or life-threatening immune responses when used in neurosurgical procedures. These contaminants can lead to systemic illness or fever in patients.

What You Should Do

  1. This recall involves Integra Extended Tip Applicators in 8CM (Box of 5 and Box of 1) and 15CM (Box of 5) sizes, including all lot numbers for models 205108, 205115, and 201108.
  2. Stop using the recalled device immediately.
  3. Contact the manufacturer, Integra LifeSciences, or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Clinical/Hospital device return

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Extended Tip Applicator, 8CM (Box of 5)
Variants: 8CM, Box of 5
Model / REF:
205108
Lot Numbers:
All Lots
UDI:
10381780000143

Recall #: Z-1958-2025

Product: Extended Tip Applicator, 15 CM (Box of 5)
Variants: 15 CM, Box of 5
Model / REF:
205115
Lot Numbers:
All Lots
UDI:
10381780000150

Recall #: Z-1959-2025

Product: Extended Tip Applicator, 8CM (Box of 1)
Variants: 8CM, Box of 1
Model / REF:
201108
Lot Numbers:
All Lots
UDI:
10381780000167

Recall #: Z-1960-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96934
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: Integra LifeSciences Corp. (NeuroSciences)
Manufactured In: United States
Units Affected: 3 products (6,216 units; 2,524 units; 212 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.