The Recall Desk

Manufacturer

MicroAire Surgical Instruments, LLC

14 recalls in our database name MicroAire Surgical Instruments, LLC as the manufacturing or recalling firm.

What the numbers show

Total
14
Critical
0
Severe
1
Most recent
2025-06-18

Of the 14 recalls from MicroAire Surgical Instruments, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

  • HighFDA (Devices)·Z-1975-2025·2025-06-18

    SmartRelease Onyx Blade Assembly Surgical System Recalled

    MicroAire Surgical Instruments is recalling the SmartRelease ESTR Onyx Blade Assembly due to a potential risk that the blade can unintentionally cut tissue before the user deploys it.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2019·2019-08-14

    MicroAire SmartRelease Endoscopic Carpal Tunnel Handpiece Recall

    MicroAire is recalling 103 SmartRelease Endoscopic Carpal Tunnel Release Handpieces because the blade may fail to retract when tightened.

    Product
    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2107-2018·2018-06-13

    MicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions

    MicroAire is recalling SmartRelease Endoscopic Systems because the Instructions for Use contain incorrect sterilization parameters.

    Product
    MicroAire 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2018·2018-02-07

    MicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion

    MicroAire Surgical Instruments is recalling 42 sterile twist drills because one lot contained an incorrect 2.0mm drill alongside the correct 1.6mm drill.

    Product
    SST 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 bone
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1407-2017·2017-03-15

    MicroAire K-Wires Recalled for Incorrect Product Labeling

    MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.

    Product
    MicroAire K-Wires
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1834-2016·2016-06-08

    MicroAire Pneumatic Impactor Recall for Missing Symbol Markings

    MicroAire is recalling 20 Pneumatic Impactor units because they are missing required lock and unlock symbol markings.

    Product
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1323-2016·2016-04-13

    MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking

    MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.

    Product
    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2016·2016-04-13

    MicroAire PAL-R4011XL Cannula Recalled Due to Breakage During Surgery

    MicroAire is recalling PAL-R4011XL cannulas because three reports indicated the devices bent or broke during surgical procedures.

    Product
    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2822-2015·2015-10-07

    MicroAire LipoTower Recalled for Potential Electrical Shock Hazard

    MicroAire Surgical Instruments is recalling 168 LipoTower units due to a risk of electrical shock if internal lead wires detach and the ground connection fails.

    Product
    ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2015·2015-10-07

    MicroAire LipoTower Recall Due to Electrical Shock Risk

    MicroAire Surgical Instruments is recalling three LipoTower units with aspiration pumps due to a potential risk of electrical shock if internal lead wires detach.

    Product
    ASP-1020 LipoTower with Aspiration Pump. Medical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2159-2013·2013-09-11

    MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals

    MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Kirschner-Wire (K-Wire), 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-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2013·2013-09-11

    MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise

    MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Steinmann 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 1636-509 162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2012·2012-06-20

    MicroAire Lipofilter 3000 Canisters Recalled for Sterilization Defects

    MicroAire Surgical Instruments is recalling 15 Lipofilter 3000 fat collection canisters because they were not manufactured under Good Manufacturing Procedures, potentially preventing proper sterilization.

    Product
    Lipofilter 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide