Drug recall
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name…
FDA recall event 96868 · Class II · MicroAire Surgical Instruments, LLC
Key facts
| Event ID | 96868 |
|---|---|
| Recall numbers | Z-1975-2025 |
| Recalling firm | MicroAire Surgical Instruments, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. |
| Initiation date | May 7, 2025 |
| Report date | Jun 18, 2025 |
| City | Charlottesville |
| State | VA |
| Country | United States |
| FEI number | 2020601 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: