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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 9 of 40

Device	Model / Reference	Registries	Class	Status
Depuy®	5402-06	FDA UDI	Class I	Unknown
Skeeter®	3155615	FDA UDI	Class II	Active
Aps™	8228053	FDA UDI	Class II	Active
Robinson	1133006	FDA UDI	Class II	Unknown
Visao™	3334800T	FDA UDI	Class II	Active
Nim®	8229308	FDA UDI	Class II	Unknown
NIM-Neuro®	8253401	FDA UDI	Class II	Active
Merocel®	300510	FDA UDI	Class II	Unknown
Merocel®	300501	FDA UDI	Class II	Unknown
Paparella	1040006	FDA UDI	Class II	Active
Slide-On®	226301	FDA UDI	Class II	Unknown
Otomag™ Alpha 2 Sound Processor	S0415-02	FDA UDI	Class II	Unknown
Attract™	S0542-04	FDA UDI	Class II	Unknown
Paparella	14521	FDA UDI	Class II	Active
Merocel® ELVIS®	400751	FDA UDI	Class II	Active
Mortez	1156379	FDA UDI	Class II	Unknown
Merocel®	400141	FDA UDI	Class I	Active
Otomag™ Alpha 2 Sound Processor	S0415-03	FDA UDI	Class II	Active
Paparella	MV1027	FDA UDI	Class II	Active
Endo-Scrub®	1912000	FDA UDI	Class II	Unknown
Rad®	1883070	FDA UDI	Class I	Active
Soileau Tytan	1056101	FDA UDI	Class II	Active
Hubbard	1056170	FDA UDI	Class II	Active
ViSAO®	31180598E	FDA UDI	Class I	Active
Baxter	14612	FDA UDI	Class II	Active
Reuter Venturi™	1070031	FDA UDI	Class II	Active
Slide-On®	336301	FDA UDI	Class II	Unknown
Shepard	1016101	FDA UDI	Class II	Active
McGee	1156346	FDA UDI	Class II	Unknown
McGee	1156330	FDA UDI	Class II	Active
Microgel	25441	FDA UDI	Class II	Active
ViSAO®	311715115E	FDA UDI	Class I	Active
Austin	1156305	FDA UDI	Class II	Active
Paparella	1040019	FDA UDI	Class II	Active
Millen / Flex H/A®	0568	FDA UDI	Class II	Active
Oto-Flex	3155623	FDA UDI	Class I	Active
Fusion® Quadcut®	1883480EM	FDA UDI	Class II	Active
Fisch	1156308	FDA UDI	Class II	Unknown
NIM TriVantage™	8229705	FDA UDI	Class II	Unknown
ViSAO®	311710115E	FDA UDI	Class I	Active
Midas Rex™	EDT200	FDA UDI	Class II	Active
Bio-Flek	1358225	FDA UDI	Class I	Unknown
Brackmann	1156303	FDA UDI	Class II	Active
Mortez	1156377	FDA UDI	Class II	Unknown
NuVent ™	1830717SPH	FDA UDI	Class I	Unknown
Moretz Tytan®	1056104	FDA UDI	Class II	Active
Propel	50011-	FDA UDI	Class III	Active
Reuter Tytan®	1066110	FDA UDI	Class II	Unknown
Nim-Eclipse®	ECLC	FDA UDI	Class II	Active
Reuter	1010203	FDA UDI	Class II	Active

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Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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.