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 Insight

This FDA Devices action (record #Z-1975-2025) was formally reported on June 18, 2025, with the manufacturer initiating the action on May 7, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. MicroAire Surgical Instruments, LLC is listed as the recalling firm, operating out of Charlottesville, VA. Federal records indicate 1,451 eaches units are affected.

The documented reason for this recall is: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.