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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

MicroMyst Applicator Recalled for Lack of Sterility Assurance

Agency Publication Date: June 20, 2025
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Summary

Integra LifeSciences Corp. (NeuroSciences) has recalled 4,882 units of the MicroMyst Applicator (Model 205000DS). This applicator is used with the Integra Flow Source to deliver two liquids simultaneously during medical procedures. The recall was initiated because the products lack sterility assurance, meaning they may not be completely free of bacteria or other pathogens. No injuries or incidents have been reported to date.

Risk

Using a non-sterile medical device during surgery can introduce harmful pathogens directly into a patient's body. This poses a critical risk of serious infection, which could lead to severe health complications or life-threatening conditions.

What You Should Do

  1. This recall affects all lots of the MicroMyst Applicator, sold in boxes of 5, which consist of a multilumen applicator and filtered line for use with the Integra Flow Source.
  2. Identify affected units by checking the packaging for Model/Catalog Number 205000DS and Unique Device Identifier (UDI) 10381780000112.
  3. Stop using the recalled device immediately and remove any remaining inventory from clinical areas to prevent accidental use.
  4. Contact Integra LifeSciences Corp. or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MicroMyst Applicator (Box of 5)
Model / REF:
205000DS
UDI:
10381780000112

All lots are affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96965
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 4,882 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.