FDA Medical Device Recalls (openFDA)
MicroAire Surgical Instruments, LLC: 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);
- Recall number
- Z-1975-2025
- Recalling firm
- MicroAire Surgical Instruments, LLC
- 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);
- Status
- Open, Classified
- Initiated
- 2025-05-07
- Posted
- 2025-06-12
- Terminated
- not on file
- Reason
- Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
- Root cause
- Under Investigation by firm
- Action
- On May 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Specifically, we re asking that you please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309, and to send back your unused product, per the directions. MicroAire will replace these unused units free of charge. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of 8:30 AM and 5:00 PM (EST) Monday through Friday. We apologize for this inconvenience and are taking the proper steps to ensure that this will not happen in the future.
- Quantity
- 1,451 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K223406"]
- PMA numbers
- not on file
- Product code
- EMF
- Firm FEI
- 2020601
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28