Integra MicroMyst Applicator recalled worldwide for sterility deficiency
Integra LifeSciences' MicroMyst Applicator has been recalled worldwide due to lack of sterility assurance affecting approximately 4,882 units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class I recall for a medical device with a sterility assurance defect. Although no illnesses or injuries have been reported, the sterility issue poses a significant risk of contamination. The Class I classification indicates serious potential consequences, but the absence of reported adverse events places it in the High category rather than Severe or Critical.
Plain-English summary
The MicroMyst Applicator, a multilumen medical device consisting of an applicator and filtered line used with the Integra Flow Source for controlled application of two liquids, has been recalled due to lack of sterility assurance.
Approximately 4,882 units have been distributed worldwide, including throughout the United States and in 21 countries including Taiwan, Vietnam, Brazil, Canada, Australia, and multiple European nations. All lots of this device (Model 205000DS, UDI 10381780000112) are subject to this recall.
The FDA has classified this as a Class I recall, indicating a serious potential health risk due to the device's inability to maintain required sterility standards.
The recalled product
- Product
- 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.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: 205000DS
- UDI No. 10381780000112
- All lots.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03