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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Affected units
- 103
Distribution
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