Brand Name: SmartRelease ESTR — Class II medical device recall Z-1975-2025
Ongoing recall by MicroAire Surgical Instruments, LLC, reported 2025-06-18, distributed nationwide. Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
| Recall number | Z-1975-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroAire Surgical Instruments, LLC, Charlottesville, VA, United States |
| Recall initiated | 2025-05-07 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK, GB |
| Quantity | 1,451 eaches |
| UPC / GTIN / UDI-DI | 00847399015860, 00847399017246 |
| Lot numbers | 104841032025, 104842032025, 104865032025, 104873032025, 104885042025, 104902042025 |
| Model numbers | 83030-1, 83030-6, 83030-6-CE |
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 for recall
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1975-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.