MicroMyst Applicator recall: Sterility Concern
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled…
Why was MicroMyst Applicator recalled?
Lack of sterility assurance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
- Product
- MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled…
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 4,882 units
- Distribution
- 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.
- Recall date
- July 2, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)