Recall Z-1961-2025 ยท FMF Syringe, Piston
Integra LifeSciences Corp. (NeuroSciences)
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.
| Date | Jun 20, 2025 (initiated May 23, 2025) |
| Status | Open, Classified |
| Reason | Lack of sterility assurance. |
| Root cause | Process change control |
| Action | A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" notification dated 5/23/25 was mailed to consignees. The notification instructs customers to identify affected devices in inventory and immediately place them in quarantine. The provided Acknowledgement Form is to be completed and returned via email to FCA1@integralife.com or FAX at 1-609-750-4220. Customers are to keep a copy of the notification for their records and forward a copy to users. A Returned Materials Authorization number and instructions to return product will be provided by Customer Service upon receipt of the comple |
| 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 a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082454 | MICROMYST APPLICATOR, MODEL 20-5000 Covidien, Nov 7, 2008 |