MicroAire Surgical Instruments, LLC: Device Recall
Recall #Z-1975-2025 · 05/07/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1975-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- MicroAire Surgical Instruments, LLC
- Status
- Ongoing
- Date Initiated
- 05/07/2025
- Location
- Charlottesville, VA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,451 eaches
Reason for Recall
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Product Description
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);
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.