[pending] Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alter
Pending LLM rewrite. Source: FDA_DEVICE Z-1975-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
The recalled product
- Product
- 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
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
Distribution
Distributed nationwide across the United States.
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