FDA Device recall Z-1975-2025
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly by Microaire Surgical Instruments, citing potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1975-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-07 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microaire Surgical Instruments |
| Distribution | US |
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) and 83030-6-CE (six pack OUS only);
Reason
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Identifiers
| 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…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1975-2025%22
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