MicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions
MicroAire is recalling SmartRelease Endoscopic Systems because the Instructions for Use contain incorrect sterilization parameters.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a documentation error (incorrect IFU) rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling the MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece. The recall involves 2,009 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall is being conducted because the Instructions for Use (IFU) revision D contains incorrect information regarding sterilization parameters. The device is indicated for releasing the transverse carpal ligament in patients with idiopathic carpal tunnel syndrome.
Healthcare providers and facilities should stop using the affected devices and contact MicroAire Surgical Instruments, LLC for instructions on replacing the incorrect IFU. The affected products were distributed between January 1, 2013, and February 23, 2018.
The recalled product
- Product
- MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any…
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Affected units
- 2,009
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products distributed from 1/1/13 to 2/23/18
Distribution
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