Integra LifeSciences Corp. (NeuroSciences) medical device recall: MicroMyst Applicator
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96965
- Recall initiated
- May 23, 2025
- Classified by FDA
- Jun 20, 2025
- Posted in Enforcement Report
- Jul 2, 2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Firm location
- Princeton, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Lack of sterility assurance.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 23, 2025. FDA classified it 28 days later, on Jun 20, 2025. Distribution reported by FDA: Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom. Integra LifeSciences Corp. (NeuroSciences) has 13 recalls in our records.
Recalled products (1)
Z-1961-2025 Class I Ongoing
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Codes / lots: Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Quantity: 4,882 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96965
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.