Class II — MicroAire Surgical Instruments, LLC
| Recalling firm | MICROAIRE SURGICAL INSTRUMENTS, LLC |
|---|---|
| Registered facility | MICROAIRE SURGICAL INSTRUMENTS LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There was a higher than normal incidence rate of the blade not retracting when tightening. |
| Product | SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 |
| Quantity | 103 |
| 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 | 2019-06-26 |
| Classified | 2019-08-08 |
| Terminated | 2020-04-29 |
| Recall number | Z-2222-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MicroAire Surgical Instruments, LLC (Z-2222-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83283/
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