Z-1975-2025Class II

Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name...

Name: Z-1975-2025 Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name...
Creator: MicroAire Surgical Instruments, LLC
Published: 2025-05-07
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2025-05-07 / Open, Classified

FDA source

MicroAire Surgical Instruments, LLC began a recall of Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System... on 2025-05-07. FDA classified it as Class II and gives the reason as "Potential that the blade can unintentionally cut tissue prior to the user deploying the blade". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1975-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-07
Posted: 2025-06-12
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);
Product code: EMF Knife, Surgical
Reason for recall: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
FDA 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 [email protected] 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 in commerce: 1,451 eaches
Distribution: Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1975-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1975-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code EMF

K223406Class IISmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments / cleared 2023-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)