The Recall Desk
HighFDA (Devices)·Z-2222-2019·Announced 2019-08-14

MicroAire SmartRelease Endoscopic Carpal Tunnel Handpiece Recall

MicroAire is recalling 103 SmartRelease Endoscopic Carpal Tunnel Release Handpieces because the blade may fail to retract when tightened.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect (blade not retracting) that poses a risk of harm during surgery, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

MicroAire Surgical Instruments, LLC is recalling 103 units of the SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014. The recall was initiated because there was a higher than normal incidence rate of the blade not retracting when tightening.

The affected products were distributed to 26 US states, including California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and Wyoming. The products were also distributed to Australia, the Czech Republic, France, Germany, and Taiwan.

Healthcare providers and patients should check their inventory or medical records for the specific serial numbers listed in the official recall notice. If a device is found, it should be removed from service and returned to MicroAire Surgical Instruments, LLC for evaluation or replacement.

The recalled product

Product
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Affected units
103

Distribution

Same manufacturer · MicroAire Surgical Instruments, LLC

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