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U.S. Department of Health and Human Services

Class 2 Device Recall SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly

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 Class 2 Device Recall SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assemblysee related information
Date Initiated by FirmMay 07, 2025
Date PostedJune 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1975-2025
Recall Event ID 96868
510(K)NumberK223406 
Product Classification Knife, surgical - Product Code EMF
ProductBrand 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);
Code Information 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;
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
For Additional Information ContactMicroAire Customer Service
800-722-0822
Manufacturer Reason
for Recall		Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce1,451 eaches
DistributionWorldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EMF
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