Recall Z-1975-2025 ยท EMF Knife, Surgical
MicroAire Surgical Instruments, LLC
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
| Date | Jun 12, 2025 (initiated May 7, 2025) |
| Status | Open, Classified |
| Reason | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. |
| Root cause | Under Investigation by firm |
| Action | On May 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Specifically, we re asking that you please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309, and to send back your unused product, per the directions. MicroAire will replace these unused units free of charge. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of 8:30 AM and 5:00 PM (EST) Monday through Friday. We apologize for this inconvenience and are taking the proper steps to ensure that th |
| Quantity | 1,451 eaches |
| Distribution | Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223406 | SmartRelease Endoscopic Soft Tissue Release System Microaire Surgical Instruments, Feb 2, 2023 |