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Sign in to claim this brandMicroAire Surgical Instruments LLC
United States·US-MF-000004063
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3590 Grand Forks Boulevard, Charlottesville, United States
- Website
- microaire.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Chad Wade
- EUDAMED SRN
- US-MF-000004063
- FDA FEI Number
- 2020601
- DUNS Number
- —
Catalogue (1286)
Page 25 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MicroAire® | ZS-038 | FDA UDI | Class I | Active |
| MicroAire® | ZO-72730 | FDA UDI | Class I | Active |
| MicroAire® | 1632-109TNS | FDA UDI | Class II | Active |
| MicroAire® | 1632-609 | FDA UDI | Class II | Active |
| MicroAire® | 8053-132 | FDA UDI | Class I | Unknown |
| MicroAire® | PAL-R505LL | FDA UDI | Class II | Active |
| MicroAire® | PAL-304LL | FDA UDI | Class II | Active |
| MicroAire® | 1624-709 | FDA UDI | Class II | Active |
| MicroAire® | 201-05-00 | FDA UDI | Class II | Active |
| MicroAire® | K-70 | FDA UDI | Class I | Unknown |
| MicroAire® | PAL-402LS | FDA UDI | Class II | Active |
| MicroAire® | CC-1000NS | FDA UDI | Class I | Unknown |
| MicroAire® | PAL-INF-408LL | FDA UDI | Class II | Active |
| MicroAire® | ZB-73 | FDA UDI | Class I | Active |
| MicroAire® | K-28 | FDA UDI | Class I | Unknown |
| MicroAire® | 1636-609NS | FDA UDI | Class II | Active |
| MicroAire® | ZO-7205 | FDA UDI | Class I | Active |
| MicroAire® | ZB-192 | FDA UDI | Class I | Active |
| MicroAire® | SP-206 | FDA UDI | Class I | Unknown |
| MicroAire® | 1600-935NS | FDA UDI | Class II | Active |
| Light Post Adapter, Wolf, SmartRelease | 81152-CE | EUDAMEDFDA UDI | Class I | Active |
| Dilator - Small, SmartRelease | 81026-CE | EUDAMEDFDA UDI | Class I | Active |
| Light Post Adapter, Storz, SmartRelease | 81151-CE | EUDAMEDFDA UDI | Class I | Active |
| Dilator - Medium, SmartRelease | 81027-CE | EUDAMEDFDA UDI | Class I | Active |
| AutoClavable Endoscope, SmartRelease | 81025-CE | EUDAMEDFDA UDI | Class IIa | Active |
| LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | K150779 | FDA 510(k) | Class II | Active |
| Micro-Aire Wire Pass And Craniotome Drill | K903664 | FDA 510(k) | Class II | Active |
| Microaire Smartdrive System | K955591 | FDA 510(k) | Class I | Active |
| Micro-Aire Replac. Drill Burs For Zimmer | K821695 | FDA 510(k) | Class I | Active |
| Microguard, Orthopedic Pin Protectors | K902676 | FDA 510(k) | Class II | Active |
| PAL Single-Use Cannulas | K192694 | FDA 510(k) | Class II | Active |
| Micro-Aire Stapes Drill System | K854332 | FDA 510(k) | Class II | Active |
| Micro-Aire Cutters For Midas-Rex Instruments | K894438 | FDA 510(k) | Class I | Active |
| Micro-Aire Pulse Lavage | K874504 | FDA 510(k) | Class II | Active |
| Twist Lock Drill 1120 | K831675 | FDA 510(k) | Class I | Active |
| Arthroscopic Surgery Blades (several Models) | K902168 | FDA 510(k) | Class II | Active |
| Steinmann(threaded/Calibrated), Knowles&Hogie Pins | K863734 | FDA 510(k) | Class II | Active |
| Micro-Aire Disposable Mini & Maxi Lavag | K820661 | FDA 510(k) | Class II | Active |
| PAL Infiltration System | K220318 | FDA 510(k) | Class II | Active |
| Micro-Aire Generic Burs & Drills | K850497 | FDA 510(k) | Class I | Active |
| PAL Multi-Use Cannulas and PAL Manual Wand | K171286 | FDA 510(k) | Class II | Active |
| 1.1 Screwdrivers | K872490 | FDA 510(k) | Class I | Active |
| Replacement Saw Blades For Stryker Air | K820601 | FDA 510(k) | Class I | Active |
| Microaire Power Aspiration Device Pad System | K973268 | FDA 510(k) | Class II | Active |
| Micro-Aire Replacement Drill Burs | K820281 | FDA 510(k) | Class I | Active |
| Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri | K981922 | FDA 510(k) | Class II | Active |
| Replacement Hoses | K861405 | FDA 510(k) | Class I | Active |
| Oscillating Saw/ Reciprocating Saw/ Drill-Reamer | K870157 | FDA 510(k) | Class I | Active |
| Micro-Aire Sternum Saw Replacement Blades | K850483 | FDA 510(k) | Class I | Active |
| Micro-Aire High Speed Drill (2910-000) | K894606 | FDA 510(k) | Class I | Active |
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FDA Recalls (16)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 7, 2025 | Z-1975-2025 | — | open, classified | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. |
| Jun 26, 2019 | Z-2222-2019 | — | terminated | There was a higher than normal incidence rate of the blade not retracting when tightening. |
| Apr 19, 2018 | Z-2107-2018 | — | terminated | The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced. |
| May 22, 2017 | Z-0412-2018 | — | terminated | One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) |
| Feb 21, 2017 | Z-1407-2017 | — | terminated | Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856). |
| May 6, 2016 | Z-2294-2016 | — | terminated | 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). |
| Mar 11, 2016 | Z-1834-2016 | — | terminated | MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them. |
| Feb 8, 2016 | Z-1328-2016 | — | terminated | 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. |
| Feb 8, 2016 | Z-1323-2016 | — | terminated | Complaints that the cannula bent/broke during surgery. |
| Jun 12, 2015 | Z-2821-2015 | — | terminated | There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. |
| Jun 12, 2015 | Z-2822-2015 | — | terminated | There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails. |
| Aug 12, 2013 | Z-2159-2013 | — | terminated | A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility |
| Aug 12, 2013 | Z-2158-2013 | — | terminated | A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility |
| Apr 26, 2012 | Z-1792-2012 | — | terminated | Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures. |
| Sep 23, 2003 | Z-0043-04 | — | terminated | Wiring pin locking mechanism defective, potential to come apart in surgical site. |
| Sep 23, 2003 | Z-0044-04 | — | terminated | Wiring pin locking mechanism defective, potential to come apart in surgical site. |