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MEDTRONIC XOMED, INC.

Last updated September 17, 2026

Information

Country: US
Address: 6743 SOUTHPOINT DR. NORTH, Jacksonville, FL, 32216
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1045254
DUNS Number: —

Catalogue (1955)

Page 34 of 40

Device	Model / Reference	Registries	Class	Status
Paparella	1012010	FDA UDI	Class II	Unknown
Merocel®	400422	FDA UDI	Class I	Active
Nim	8225490X	FDA UDI	Class II	Active
Midas Rex Clearview™	SP14MH30T	FDA UDI	Class II	Active
Tricut	1884004HR	FDA UDI	Class I	Active
Tricut®	1883504HR	FDA UDI	Class I	Active
Endo-Scrub®	1912023	FDA UDI	Class II	Unknown
Causse	0321	FDA UDI	Class II	Active
Endo-Scrub®	1912050	FDA UDI	Class II	Unknown
Nim-Eclipse®	945NCCPULO	FDA UDI	Class II	Active
Slide-On®	445601	FDA UDI	Class II	Active
Slide-On® Endosheath®	225501	FDA UDI	Class II	Active
Otomag™ Headband	S0265-00	FDA UDI	Class II	Unknown
Sheehy	1040030	FDA UDI	Class II	Active
NIM-Pulse®	8253202	FDA UDI	Class II	Active
Midas Rex®	ED100RF	FDA UDI	Class II	Active
Otomag™ Alpha (M) Magnetic Implant	S0521-02	FDA UDI	Class II	Unknown
Neuray	8003098	FDA UDI	Class II	Unknown
Slide-On®	332401	FDA UDI	Class II	Active
Moretz	1066177	FDA UDI	Class II	Active
Silverstein	1425020	FDA UDI	Class I	Unknown
Roberson	1133064	FDA UDI	Class II	Active
Otomag™ Alpha (M) Magnetic Implant	S0521-02	FDA UDI	Class II	Unknown
Merocel®	400413	FDA UDI	Class I	Active
Midas Rex®	EA201	FDA UDI	Class II	Active
MeroPack™	1520000	FDA UDI	Class I	Active
NIM Trivantage®	8229706	FDA UDI	Class II	Active
NuVent ™	1830717FRT	FDA UDI	Class I	Active
Attract™	S0542-06	FDA UDI	Class II	Unknown
Paparella	1082201	FDA UDI	Class II	Unknown
Oto-Flex	3155648	FDA UDI	Class I	Active
T-Tube® C-Flex®	1056015	FDA UDI	Class II	Active
Armstrong	1040024	FDA UDI	Class II	Active
Goode T-Tube®	1016025	FDA UDI	Class II	Unknown
Causse	1129040	FDA UDI	Class II	Active
Nim Flex™	8229970	FDA UDI	Class II	Active
Midas Rex Clearview	SP12BA40	FDA UDI	Class II	Active
XPS® Straightshot®	1897201	FDA UDI	Class II	Unknown
Midas Rex Clearview™	SP12MH25D	FDA UDI	Class II	Active
Reuter	14132	FDA UDI	Class II	Active
Slide-On® Endosheath®	222401	FDA UDI	Class II	Active
Sheehy	1066037	FDA UDI	Class II	Active
Merocel®	440406	FDA UDI	Class I	Active
C-Flex	1524075	FDA UDI	Class I	Active
Goode T-Tube®	1016010	FDA UDI	Class II	Active
Shepard	1016103	FDA UDI	Class II	Active
Del La Cruz	1156282	FDA UDI	Class II	Unknown
Nerve Integrity Monitor (NIM) 3.0	8253200RF	FDA UDI	Class II	Active
20763000870373	1084401	FDA UDI	Class II	Active
Otomag™ Attract™ Magnetic Spacer	S0542-01	FDA UDI	Class II	Unknown

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Authorised Representatives

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Importers

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Authorities

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FDA Recalls (38)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 17, 2025	Z-2461-2025	—	open, classified	Due to out of the box wobble of the driver.
Mar 10, 2025	Z-1623-2025	—	open, classified	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.
Jul 5, 2024	Z-3130-2024	—	open, classified	Product was distributed past expiration date.
Jun 24, 2024	Z-2409-2024	—	open, classified	Potential for false negative response on the NIM Vital Nerve Monitoring System
Nov 7, 2023	Z-0696-2024	—	open, classified	Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
May 3, 2022	Z-1224-2022	—	open, classified	Software anomaly was identified.
May 3, 2022	Z-1223-2022	—	open, classified	Software anomaly was identified.
Apr 29, 2022	Z-1521-2022	—	open, classified	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Apr 29, 2022	Z-1520-2022	—	open, classified	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Apr 29, 2022	Z-1519-2022	—	open, classified	The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Dec 22, 2021	Z-0743-2022	—	open, classified	There is potential for multiple issues due to a manufacturing nonconformity.
Dec 15, 2021	Z-0961-2022	—	terminated	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.
Aug 31, 2021	Z-0156-2022	—	open, classified	There was an increase in complaints related to tip breaks and wobble/vibration.
Aug 31, 2021	Z-0158-2022	—	open, classified	There was an increase in complaints related to tip breaks and wobble/vibration.
Aug 31, 2021	Z-0157-2022	—	open, classified	There was an increase in complaints related to tip breaks and wobble/vibration.
Jun 12, 2020	Z-2673-2020	—	terminated	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.
Nov 13, 2019	Z-0735-2020	—	open, classified	Routine sterilization dose does not meet the required Sterility Assurance Level.
Nov 13, 2019	Z-0733-2020	—	open, classified	Routine sterilization dose does not meet the required Sterility Assurance Level.
Nov 13, 2019	Z-0734-2020	—	open, classified	Routine sterilization dose does not meet the required Sterility Assurance Level.
Jun 28, 2016	Z-0901-2017	—	terminated	Wire in tubing can become exposed, posing potential harm to the intubated patient.
Aug 23, 2013	Z-2284-2013	—	terminated	One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Jul 9, 2013	Z-1934-2013	—	terminated	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"
Mar 4, 2013	Z-1420-2013	—	terminated	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.
Feb 21, 2011	Z-1699-2011	—	terminated	Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan
Feb 21, 2011	Z-1700-2011	—	terminated	Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, issued a recall on the alcohol pads on Jan
Sep 27, 2010	Z-2344-2012	—	terminated	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
Sep 27, 2010	Z-2342-2012	—	terminated	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
Sep 27, 2010	Z-2343-2012	—	terminated	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
Jul 27, 2009	Z-0536-2010	—	terminated	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
Jul 27, 2009	Z-0535-2010	—	terminated	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
Jul 17, 2009	Z-0259-2010	—	terminated	An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.
Nov 21, 2008	Z-0947-2009	—	terminated	Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.
Jan 22, 2007	Z-0576-2007	—	terminated	A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
Oct 29, 2004	Z-0310-05	—	terminated	The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
Jan 29, 2004	Z-0953-04	—	terminated	The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.
Jan 29, 2004	Z-0954-04	—	terminated	The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.
Jan 29, 2004	Z-0955-04	—	terminated	The box label indicates that the product is a size 2 whereas a size 4 was packed inside.
Jan 25, 2002	Z-0662-03	—	terminated	Product packaging pouches may be open thereby compomising the sterile barrier.