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MicroAire Surgical Instruments, LLC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for MicroAire Surgical Instruments, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-18FDA-DeviceClass IIBrand 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);
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
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