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MicroAire Surgical Instruments Recalls
14 recalls on record · June 20, 2012 to June 18, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 18, 2025Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End
Hazard: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
August 14, 2019Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Hazard: There was a higher than normal incidence rate of the blade not retracting when tightening.
June 13, 2018Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev.
Hazard: The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
February 7, 2018Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopa
Hazard: One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
March 15, 2017Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls MicroAire K-Wires
Hazard: 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).
August 3, 2016Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls Endotine Transbleph 3.5 (CFD-080-0167)
Hazard: 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).
June 8, 2016Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Hazard: 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.
April 13, 2016Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
Hazard: 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.
April 13, 2016Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Hazard: Complaints that the cannula bent/broke during surgery.
October 7, 2015Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
Hazard: There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
October 7, 2015Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls ASP-1020 LipoTower with Aspiration Pump. Medical use.
Hazard: There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
September 11, 2013Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales
Hazard: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
September 11, 2013Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouc
Hazard: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
June 20, 2012Medical DevicesFDA
MicroAire Surgical Instruments, LLC recalls Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA***
Hazard: Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.