Medical DeviceJun 18, 2025
SmartRelease ESTR recall — FDA Z-1975-2025
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Class IIFDA: OngoingMicroAire Surgical Instruments, LLC
Recall history in this database
Classification mix: Class II: 3.
Medical DeviceAug 14, 2019
MicroAire Surgical Instruments SmartRelease Endoscopic Carpal Tunnel Release Handpiece recall — FDA Z-2222-2019
There was a higher than normal incidence rate of the blade not retracting when tightening.
Class IIFDA: TerminatedMicroAire Surgical Instruments, LLC
Medical DeviceJun 13, 2018
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease recall — FDA Z-2107-2018
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Class IIFDA: TerminatedMicroAire Surgical Instruments, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies MicroAire Surgical Instruments, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.