FDAFDA · Food and drugs·Recall number Z-1975-2025
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);
Published June 18, 2025 · Recall initiated: May 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
- Lot
- Catalog (SKU) Numbers:(1) 83030-1 (single pack), (2) 83030-6 (six pack) and (3) 83030-6-CE (six pack OUS only); UDI-DI: (1) 00847399017246 (single pack), (2&3) 00847399015860 (six pack); Lot Numbers: (1) 104842032025, (2) 104841032025, 104873032025, 104885042025, 104902042025, (3) 104865032025;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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