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 | MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177). |
| Product | Endotine Transbleph 3.5 (CFD-080-0167) |
| Quantity | 29 |
| Distribution | The product was distributed in the United States and Sweden |
| Initiated | 2016-05-06 |
| Classified | 2016-07-27 |
| Terminated | 2016-08-12 |
| Recall number | Z-2294-2016 |
| 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-2294-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74222/
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