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    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

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    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 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

    Cascade IOMAX Cortical Module, REF: 190296-200

    FDA Recall
    Open, Classified ·Cadwell Industries Inc·Product code GWF·April 23, 2024

    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

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    Cascade IOMAX Cortical Module, REF: 190296-200

    FDA Recall
    Open, Classified ·Cadwell Industries Inc·Product code GWF·May 17, 2024

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023

    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDS·October 31, 2024

    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDS·April 22, 2022

    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDS·September 18, 2024

    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023

    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023

    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FET·August 21, 2024

    Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·December 12, 2024

    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

    Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·February 5, 2025

    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·April 21, 2026