Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End
Summary
The FDA issued a Class II for Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx B by MicroAire Surgical Instruments, LLC. Reason: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade..
Details
Source
Device Recall
External ID
Z-1975-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
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);
Lot/Code Info: 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;
Quantity Affected: 1,451 eaches
Reason for Recall
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Distribution
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-07
Company
Charlottesville, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MicroAire Surgical Instruments, LLC has 6 FDA actions in our database, including 1 recall and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MicroAire Surgical Instruments, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MicroAire Surgical Instruments, LLC have FDA actions?
MicroAire Surgical Instruments, LLC has 6 FDA actions in our database, including 1 recall and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1975-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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