RegWardenFDA facility compliance records
Company

MICROAIRE SURGICAL INSTRUMENTS, LLC

12 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2015: 1 recalls; 2016: 4 recalls; 2017: 2 recalls; 2018: 1 recalls; 2019: 1 recalls; 2025: 1 recalls1’121’13’141’154’162’171’181’19’20’21’22’23’241’25’26
  • Recalls (12)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “MICROAIRE SURGICAL INSTRUMENTS, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9004658-microaire-surgical-instruments-llc/

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