Charlottesville, VA, United States
MicroAire Surgical Instruments, LLC recalls
4 recalls recorded since 2018, most recently on 7 May 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 May 2025
- Reason
- Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1975-2025
- Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Cat
Terminated Class II Medical devices
- Recall started
- 26 June 2019
- Terminated
- 29 April 2020
- Reason
- There was a higher than normal incidence rate of the blade not retracting when tightening.
- Distribution
- The products were distributed to the following US states: CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Czech Republic, France, Germany, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2222-2019
- SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Terminated Class II Medical devices
- Recall started
- 19 April 2018
- Terminated
- 10 April 2020
- Reason
- The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
- Distribution
- 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, Se
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2107-2018
- 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
Terminated Class II Medical devices
- Recall started
- 22 May 2017
- Terminated
- 29 August 2018
- Reason
- One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
- Distribution
- US Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0412-2018
- SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.