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Medtronic Xomed Recalls
26 recalls on record · September 19, 2012 to September 3, 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.
September 3, 2025Medical DevicesFDA
Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for
Hazard: Due to out of the box wobble of the driver.
April 30, 2025Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,
Hazard: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
September 18, 2024Medical DevicesFDA
Medtronic Xomed, Inc. recalls Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Hazard: Product was distributed past expiration date.
July 31, 2024Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.
Hazard: Potential for false negative response on the NIM Vital Nerve Monitoring System
January 17, 2024Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c
Hazard: Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
September 7, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Hazard: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
September 7, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Hazard: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
September 7, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Hazard: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
June 8, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Hazard: Software anomaly was identified.
June 8, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Hazard: Software anomaly was identified.
April 27, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFU
Hazard: As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
March 16, 2022Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube
Hazard: There is potential for multiple issues due to a manufacturing nonconformity.
October 27, 2021Medical DevicesFDA
Medtronic Xomed, Inc. recalls Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation
Hazard: There was an increase in complaints related to tip breaks and wobble/vibration.
October 27, 2021Medical DevicesFDA
Medtronic Xomed, Inc. recalls Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation
Hazard: There was an increase in complaints related to tip breaks and wobble/vibration.
October 27, 2021Medical DevicesFDA
Medtronic Xomed, Inc. recalls Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation
Hazard: There was an increase in complaints related to tip breaks and wobble/vibration.
July 29, 2020Medical DevicesFDA
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, dr
Hazard: During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
January 1, 2020Medical DevicesFDA
Medtronic Xomed, Inc. recalls Lamicel 10PK 10MM INTL
Hazard: Routine sterilization dose does not meet the required Sterility Assurance Level.
January 1, 2020Medical DevicesFDA
Medtronic Xomed, Inc. recalls Lamicel 20PK 5MM INTL
Hazard: Routine sterilization dose does not meet the required Sterility Assurance Level.
January 1, 2020Medical DevicesFDA
Medtronic Xomed, Inc. recalls Lamicel 20PK 3MM INTL Cervical dilator
Hazard: Routine sterilization dose does not meet the required Sterility Assurance Level.
January 4, 2017Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Hazard: Wire in tubing can become exposed, posing potential harm to the intubated patient.
October 2, 2013Medical DevicesFDA
Medtronic Xomed, Inc. recalls Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated
Hazard: One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
August 21, 2013Medical DevicesFDA
Medtronic Xomed, Inc. recalls Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments u
Hazard: The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
June 12, 2013Medical DevicesFDA
Medtronic Xomed, Inc. recalls REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Dr
Hazard: In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
September 19, 2012Medical DevicesFDA
Medtronic Xomed, Inc. recalls Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse).
Hazard: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
September 19, 2012Medical DevicesFDA
Medtronic Xomed, Inc. recalls Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro).
Hazard: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
September 19, 2012Medical DevicesFDA
Medtronic Xomed, Inc. recalls Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LA
Hazard: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu