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    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code GWF·June 24, 2024

    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·April 29, 2022

    NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·April 29, 2022

    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·April 29, 2022

    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code GWF·March 10, 2025

    NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code GWF·May 3, 2022

    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code GWF·May 3, 2022

    NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·November 7, 2023

    NIM TRIVANTAGE EMG Endotracheal Tube

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·December 22, 2021

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM;

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NIM·July 7, 2025

    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40

    FDA Recall
    Open, Classified ·Contego Medical LLC·Product code NIM·September 4, 2025

    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.

    FDA Recall
    Open, Classified ·Cardinal Health Inc.·Product code NIM·November 14, 2019

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·May 6, 2022

    MIM software; System, Image Processing, Radiological

    FDA Recall
    Open, Classified ·MIM Software Inc·Product code LLZ·February 19, 2025