Medtronic Xomed, Inc.
Jacksonville, FL
This page shows every FDA and USDA recall linked to Medtronic Xomed, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
38
Total Recalls
2002
First Recall
2025
Most Recent
IPC Powerease System REF 2300000
UDI-DI:
00613994448705
00643169406834.
The IPC POWEREASE System is indicated...
Aug 27, 2025
· Device
Open, Classified
NIM Vital Nerve Monitoring System:
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;
CONSOLE NIM4CM01RF NIM 4.0 REFUR...
Apr 18, 2025
· Device
Open, Classified
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Sep 12, 2024
· Device
Open, Classified
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v...
Jul 24, 2024
· Device
Open, Classified
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes:
a) 8229706, 6.0MM ID;
b) 8229707, 7.0MM...
Jan 10, 2024
· Device
Open, Classified
NIM CONTACT EMG Endotracheal Tube, Part Numbers:
a) REF 8229508
b) REF 8229507
c) REF 8229506
Sep 1, 2022
· Device
Open, Classified
NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229307J
b) REF 8229308J
c) REF 8229306J
Sep 1, 2022
· Device
Open, Classified
NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229308
b) REF 8229307
c) REF 8229306
Sep 1, 2022
· Device
Open, Classified
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Jun 2, 2022
· Device
Open, Classified
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Jun 2, 2022
· Device
Open, Classified
NIM TRIVANTAGE EMG Endotracheal Tube
Dec 22, 2021
· Device
Open, Classified
Software 1898072 IPC upgrade v 2.7.3.0, IPC System:
a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE...
Dec 15, 2021
· Device
Terminated
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT...
Oct 21, 2021
· Device
Open, Classified
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT...
Oct 21, 2021
· Device
Open, Classified
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT...
Oct 21, 2021
· Device
Open, Classified
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting r...
Jun 12, 2020
· Device
Terminated
Lamicel 20PK 3MM INTL Cervical dilator
Nov 13, 2019
· Device
Open, Classified
Lamicel 20PK 5MM INTL
Nov 13, 2019
· Device
Open, Classified
Lamicel 10PK 10MM INTL
Nov 13, 2019
· Device
Open, Classified
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually pack...
Jun 28, 2016
· Device
Terminated
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and...
Sep 26, 2013
· Device
Terminated
Tray Surgical, ENT (various instrument trays)
Used for stot age and transportation of reusable surgical instr...
Aug 9, 2013
· Device
Terminated
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Sou...
Jun 4, 2013
· Device
Terminated
Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Ne...
Sep 10, 2012
· Device
Terminated
Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pu...
Sep 10, 2012
· Device
Terminated
Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Respon...
Sep 10, 2012
· Device
Terminated
An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilizati...
Mar 17, 2011
· Device
Terminated
Recall of Alcohol Pads contained in the following kits distributed by Medtronic:
***REF 1529100***Therm...
Mar 17, 2011
· Device
Terminated
Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.
Distributed by Medtronic Xomed, Inc. Jack...
Dec 15, 2009
· Device
Terminated
Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200.
Distributed by Medtronic Xomed, Inc., Jacksonvi...
Dec 15, 2009
· Device
Terminated
Medtronic Integrated Power Console System, IP X1
REF 1898001 or REF EC300
Medtronic Xomed, Inc., 6743 Southp...
Nov 13, 2009
· Device
Terminated
VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc.
The Vari-Stim III nerve locator/stimu...
Mar 3, 2009
· Device
Terminated
AccuGuide Injection Needles (Surface electrodes)
The AccuGuide EMG Injection Needle, product 8263210, conta...
Mar 7, 2007
· Device
Terminated
Brand name:
NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108
NIM EMG...
Dec 15, 2004
· Device
Terminated
Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.
Jul 20, 2004
· Device
Terminated
The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
Jul 20, 2004
· Device
Terminated
Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83...
Jul 20, 2004
· Device
Terminated
Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is furth...
Mar 20, 2003
· Device
Terminated