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MicroAire 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Chad Wade
EUDAMED SRN: US-MF-000004063
FDA FEI Number: 2020601
DUNS Number: —

Catalogue (1286)

Page 5 of 26

Device	Model / Reference	Registries	Class	Status
MicroAire®	K-36	FDA UDI	Class I	Unknown
MicroAire®	1604-145NS	FDA UDI	Class II	Active
MicroAire®	ZS-336	FDA UDI	Class I	Active
MicroAire®	1636-609TNS	FDA UDI	Class II	Active
MicroAire®	1600-454	FDA UDI	Class II	Active
MicroAire®	CFD-060-0197	FDA UDI	Class II	Active
MicroAire®	1620-709TNS	FDA UDI	Class II	Active
MicroAire®	ASP-CAN-NT	FDA UDI	Class II	Unknown
MicroAire®	ZB-640	FDA UDI	Class I	Active
MicroAire®	SP-224A	FDA UDI	Class I	Unknown
MicroAire®	PAL-407LL	FDA UDI	Class II	Active
MicroAire®	5740-009	FDA UDI	Class II	Unknown
MicroAire®	ZR-032NS	FDA UDI	Class I	Active
MicroAire®	ZS-038NS	FDA UDI	Class I	Active
MicroAire®	7020	FDA UDI	Class II	Active
MicroAire®	K-77	FDA UDI	Class I	Unknown
MicroAire®	PAL-508LLB	FDA UDI	Class II	Active
MicroAire®	PAL-3011LS	FDA UDI	Class II	Unknown
MicroAire®	K-42	FDA UDI	Class I	Unknown
MicroAire®	ZS-043	FDA UDI	Class I	Active
MicroAire®	ZO-7241	FDA UDI	Class I	Unknown
MicroAire®	1628-509NS	FDA UDI	Class II	Active
MicroAire®	1640-509TNS	FDA UDI	Class II	Active
MicroAire®	ZB-149	FDA UDI	Class I	Active
MicroAire®	7100-003	FDA UDI	Class I	Active
MicroAire®	ASP-CAN-2S	FDA UDI	Class II	Unknown
MicroAire®	8054-015	FDA UDI	Class I	Active
MicroAire®	1632-109	FDA UDI	Class II	Active
MicroAire®	1200-014	FDA UDI	Class I	Active
MicroAire®	5740-200	FDA UDI	Class II	Active
MicroAire®	K-15	FDA UDI	Class I	Unknown
MicroAire®	5006-PAL	FDA UDI	Class II	Active
MicroAire®	ZS-129	FDA UDI	Class I	Active
MicroAire®	1628-109TNS	FDA UDI	Class II	Active
MicroAire®	201-00-51	FDA UDI	Class II	Active
MicroAire®	ZB-646	FDA UDI	Class I	Active
MicroAire®	1624-109NS	FDA UDI	Class II	Active
MicroAire®	7205-200	FDA UDI	Class I	Active
MicroAire®	ZS-040	FDA UDI	Class I	Active
MicroAire®	SR-300	FDA UDI	Class I	Unknown
MicroAire®	8054-023	FDA UDI	Class I	Unknown
MicroAire®	ZO18-089-090	FDA UDI	Class I	Unknown
MicroAire®	ASP-FLTR2	FDA UDI	Class II	Active
MicroAire®	PAL-304LM	FDA UDI	Class II	Active
MicroAire®	2500-206	FDA UDI	Class I	Active
MicroAire®	1600-445	FDA UDI	Class II	Active
MicroAire®	1601-964	FDA UDI	Class II	Active
MicroAire®	PAL-R506LL	FDA UDI	Class II	Active
MicroAire®	SP-108	FDA UDI	Class I	Unknown
MicroAire®	K-53	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

MediMark Europe Sarl. FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.