MicroAire Surgical Instruments, LLC recalls Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system)

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

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);

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.

• FDA enforcement recordOfficial FDA database entry for Z-1975-2025
• FDA 510(k) clearance · K223406The device's official FDA premarket clearance record
• FDA device classification · EMFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MicroAire Surgical Instruments, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.