Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endosc
FDA device recall Z-1975-2025 · posted 2025-06-12 · Open, Classified
Recall details
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Reason for recall
- Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
- Action taken
- 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 this will not happen in the future.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EMF
- Quantity affected
- 1,451 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
- Date initiated
- 2025-05-07
- Date posted
- 2025-06-12
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SmartRelease Endoscopic Soft Tissue Release System (K223406) | Microaire Surgical Instruments | 2023-02-02 |