Recall Register

MicroAire Surgical Instruments, LLC: FDA recalls

FDA enforcement reports name MicroAire Surgical Instruments, LLC as the recalling firm in 12 events. The events have 14 product records. The recalls started from 2012 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

12 events, newest first.

FDA enforcement events of MicroAire Surgical Instruments, LLC
InitiatedProduct (first record)TypeClassRecordsStatus
7 May 2025Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);DeviceClass II1Ongoing
26 Jun 2019SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014DeviceClass II1Terminated
19 Apr 2018MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic…DeviceClass II1Terminated
22 May 2017SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut boneDeviceClass II1Terminated
21 Feb 2017MicroAire K-WiresDeviceClass II1Terminated
6 May 2016Endotine Transbleph 3.5 (CFD-080-0167)DeviceClass II1Terminated
11 Mar 2016Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical IndustryDeviceClass II1Terminated
8 Feb 2016MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannulaDeviceClass II1Terminated
8 Feb 2016MicroAire PAL Cannula Product Usage - Power Aspiration DeviceDeviceClass II1Terminated
12 Jun 2015ASP-1020 LipoTower with Aspiration Pump. Medical use.DeviceClass II2Terminated
12 Aug 2013Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T…DeviceClass II2Terminated
26 Apr 2012Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

MicroAire Surgical Instruments, LLC: events for each product type
TypeEvents
Device12
MicroAire Surgical Instruments, LLC: events in each class
ClassEvents
Class II12
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of MicroAire Surgical Instruments, LLC, by the year that the recall started. The largest year is 2016, with 4 events.

Official channels

Cite this page

Recall Register. MicroAire Surgical Instruments, LLC: FDA recalls. https://recallregister.com/firm/microaire-surgical-instruments-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
VA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of MicroAire Surgical Instruments, LLC have?
Class II: 12 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of MicroAire Surgical Instruments, LLC?
FDA event 96868, which the firm started on 7 May 2025. The first product in the record is: Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
How many FDA recalls of MicroAire Surgical Instruments, LLC have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.