Jacksonville, FL, United States
Medtronic Xomed, Inc. recalls
12 recalls recorded since 2018, most recently on 17 July 2025. 10 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)10
Terminated or completed2
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 17 July 2025
- Reason
- Due to out of the box wobble of the driver.
- Distribution
- U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX, O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2461-2025
- IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including
Ongoing Class II Medical devices
- Recall started
- 10 March 2025
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR and the countries of Al
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1623-2025
- 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 N
Ongoing Class II Medical devices
- Recall started
- 5 July 2024
- Reason
- Product was distributed past expiration date.
- Distribution
- International distribution to the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3130-2024
- Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Ongoing Class I Medical devices
- Recall started
- 24 June 2024
- Reason
- Potential for false negative response on the NIM Vital Nerve Monitoring System
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finla
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2409-2024
- 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 NIM
Ongoing Class II Medical devices
- Recall started
- 7 November 2023
- Reason
- Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0696-2024
- 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
Ongoing Class II Medical devices
- Recall started
- 3 May 2022
- Reason
- Software anomaly was identified.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1224-2022, Z-1223-2022
- NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
- NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Ongoing Class I Medical devices
- Recall started
- 29 April 2022
- Reason
- The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, Ind
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1520-2022, Z-1519-2022, Z-1521-2022
- NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
- NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
- NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Ongoing Class II Medical devices
- Recall started
- 22 December 2021
- Reason
- There is potential for multiple issues due to a manufacturing nonconformity.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French G
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0743-2022
- NIM TRIVANTAGE EMG Endotracheal Tube
Terminated Class II Medical devices
- Recall started
- 15 December 2021
- Terminated
- 9 June 2023
- Reason
- 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.
- Distribution
- International distribution country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0961-2022
- Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
Ongoing Class II Medical devices
- Recall started
- 31 August 2021
- Reason
- There was an increase in complaints related to tip breaks and wobble/vibration.
- Distribution
- Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Icela
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0158-2022, Z-0157-2022, Z-0156-2022
- Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) R
- Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) R
- Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) R
Terminated Class II Medical devices
- Recall started
- 12 June 2020
- Terminated
- 20 April 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA,CO, CT, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, UT, VA, WV, WA, WI. The countries of Australia, Austria, Belgium, Canada, Chin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2673-2020
- Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
Ongoing Class II Medical devices
- Recall started
- 13 November 2019
- Reason
- Routine sterilization dose does not meet the required Sterility Assurance Level.
- Distribution
- Affected product was only distributed in Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0735-2020, Z-0734-2020, Z-0733-2020
- Lamicel 10PK 10MM INTL
- Lamicel 20PK 5MM INTL
- Lamicel 20PK 3MM INTL Cervical dilator
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.