CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
MicroAire SmartRelease Endoscopic System recalled
MicroAire Surgical Instruments is recalling MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease, distributed nationwide in the US. The recall was initiated on 19 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2107-2018
- FDA event ID
- 80095
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2018
- FDA classified
- 7 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 19 Apr 2018 | Recall initiated by company | |
| 7 Jun 2018 | Classified by FDA | +49 days |
| 13 Jun 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
Where it was distributed
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
Questions about this recall
Why was it recalled?
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Which lots are affected?
All products distributed from 1/1/13 to 2/23/18
Where was it sold?
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MicroAire Surgical Instruments
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartRelease Onyx recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Other | Nationwide |
| Device | CLASS II | SmartRelease Endoscopic Carpal Tunnel Release Handpiece recalled | MicroAire Surgical Instruments | Other | 26 states |
| Device | CLASS II | Sst Twist Drill, Standard Dia recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Other | VA |
| Device | CLASS II | MicroAire K-Wires recalled by MicroAire Surgical Instruments | MicroAire Surgical Instruments | Labeling Errors | VA |
| Device | CLASS II | Endotine Transbleph 3.5 (CFD-080-0167) recalled | MicroAire Surgical Instruments | Labeling Errors | VA |
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