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);
FDA Recall Z-1975-2025 · Posted 2025-06-12
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Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusOpen, Classified
Product CodeEMF
Date Initiated2025-05-07
Product Quantity1,451 eaches
Reason for Recall
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Firm Action
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 [email protected] 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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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