MICROAIRE SURGICAL INSTRUMENTS LLC

Activity by year

Devices registered here (3)

• Knife, Surgical
  Product code EMF (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800
• Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
  Product code KCT (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6850
• Arthroscope
  Product code HRX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.1100

Recalls & enforcement

• Class IIOngoing2025-05-07
  Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
• Class IITerminated2019-06-26
  There was a higher than normal incidence rate of the blade not retracting when tightening.
• Class IITerminated2018-04-19
  The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
• Class IITerminated2017-05-22
  One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
• Class IITerminated2017-02-21
  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).
• Class IITerminated2016-05-06
  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).
• Class IITerminated2016-03-11
  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.
• Class IITerminated2016-02-08
  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.
• Class IITerminated2016-02-08
  Complaints that the cannula bent/broke during surgery.
• Class IITerminated2015-06-12
  There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
• Class IITerminated2013-08-12
  A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
• Class IITerminated2012-04-26
  Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.

FDA inspections (1)

• VAI2016-03-17
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by MICROAIRE SURGICAL INSTRUMENTS, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)