Medtronic Xomed, Inc.
FDA Regulatory Profile
Medtronic Xomed, Inc. appears in FDA public data with 26 recalls — including 5 Class I (most serious) —, 46 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2461-2025, Class II) was initiated on July 17, 2025. Its most recent 510(k) clearance was granted on February 10, 2026.
Summary
- Total Recalls
- 26 (5 Class I)
- 510(k) Clearances
- 46
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2461-2025 | Class II | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE Syst | July 17, 2025 |
| Z-1623-2025 | Class II | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF N | March 10, 2025 |
| Z-3130-2024 | Class II | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | July 5, 2024 |
| Z-2409-2024 | Class I | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: | June 24, 2024 |
| Z-0696-2024 | Class II | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 82 | November 7, 2023 |
| Z-1224-2022 | Class II | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 | May 3, 2022 |
| Z-1223-2022 | Class II | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | May 3, 2022 |
| Z-1521-2022 | Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J | April 29, 2022 |
| Z-1520-2022 | Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306 | April 29, 2022 |
| Z-1519-2022 | Class I | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506 | April 29, 2022 |
| Z-0743-2022 | Class II | NIM TRIVANTAGE EMG Endotracheal Tube | December 22, 2021 |
| Z-0961-2022 | Class II | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; | December 15, 2021 |
| Z-0157-2022 | Class II | Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and F | August 31, 2021 |
| Z-0158-2022 | Class II | Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and F | August 31, 2021 |
| Z-0156-2022 | Class II | Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and F | August 31, 2021 |
| Z-2673-2020 | Class II | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision | June 12, 2020 |
| Z-0733-2020 | Class II | Lamicel 20PK 3MM INTL Cervical dilator | November 13, 2019 |
| Z-0734-2020 | Class II | Lamicel 20PK 5MM INTL | November 13, 2019 |
| Z-0735-2020 | Class II | Lamicel 10PK 10MM INTL | November 13, 2019 |
| Z-0901-2017 | Class II | NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individ | June 28, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM | February 10, 2026 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | October 26, 2023 |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | August 30, 2023 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control P | March 21, 2022 |
| K210841 | NuVent Eustachian Tube Dilation Balloon | August 16, 2021 |
| K202623 | Novapak Nasal Sinus Packing and Stent | December 8, 2020 |
| K200759 | NIM Vital, Nerve Integrity Monitor | October 28, 2020 |
| K173855 | Sharpsite AC Rigid Endsocope | April 20, 2018 |
| K152121 | NuVent EM Sinus Dilation System | December 1, 2015 |
| K151758 | ALAR Nasal Valve Stent | October 29, 2015 |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | August 14, 2015 |
| K151067 | Ventilation (Tympanostomy) Tubes | July 22, 2015 |
| K132297 | EM SINUS DILATION SYSTEM | November 5, 2013 |
| K122391 | MEDTRONIC XOMED, INC. | January 10, 2013 |
| K122434 | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL | October 31, 2012 |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | June 27, 2012 |
| K110623 | PILLAR PALATAL IMPLANT SYSTEM | February 10, 2012 |
| K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | January 20, 2012 |
| K111520 | IPC POWEREASE SYSTEM | October 26, 2011 |
| K083124 | NIM 3.0 | February 27, 2009 |