Recall Z-1960-2025 ยท FMF Syringe, Piston
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator 8CM, Box of 1.
| Date | Jun 20, 2025 (initiated May 22, 2025) |
| Status | Open, Classified |
| Reason | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. |
| Root cause | Process change control |
| Action | An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification dated 5/22/25 was mailed to consignees for this product removal. Consignees are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. The provided notification is to be forwarded to users of affected devices and a copy retained for consignee records. A Return Material Authorization number will be generated upon receipt of the Acknowledgment Form for credit. Sales R |
| Quantity | 212 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Be |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091315 | COVIDIEN EXTENDED TIP APPLICATOR Confluent Surgical,Inc, Jun 5, 2009 |