CLASS I ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
MicroMyst Applicator, Box of Consisting of a multilumen recalled
Integra LifeSciences Corp. (NeuroSciences) is recalling MicroMyst Applicator, Box of Consisting of a multilumen applicator and filtered line for, distributed nationwide in the US. The recall was initiated on 23 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1961-2025
- FDA event ID
- 96965
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 May 2025
- FDA classified
- 20 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 May 2025 | Recall initiated by company | |
| 20 Jun 2025 | Classified by FDA | +28 days |
| 2 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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