Reported Jun 18, 2025 · Ongoing
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR…
MicroAire Surgical Instruments, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroAire Surgical Instruments, LLC · 3590 Grand Forks Blvd · Charlottesville, VA · 22911-9006
Is this the product you have?
- Brand NameSmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly
- alternate nameECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly
- Common NameSmartRelease Onyx
- Catalog (SKU) Numbers83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only)
- Lot codes and dates
- 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) 104841032025104873032025104885042025104902042025(3) 104865032025
- Amount recalled
- 1,451 eaches
Where it was sold
- Nationwide
Why it was recalled
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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