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 recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice. |
| Product | MicroAire PAL® Cannula Product Usage - Power Aspiration Device |
| Quantity | 145 manufactured and distributed |
| Distribution | Worldwide Distribution - US Nationwide |
| Initiated | 2016-02-08 |
| Classified | 2016-04-05 |
| Terminated | 2017-02-14 |
| Recall number | Z-1328-2016 |
| 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-1328-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73373/
Alerts for MICROAIRE SURGICAL INSTRUMENTS, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.