Recall Register

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Medtronic Xomed, Inc.

FDA recalling firm · 17 enforcement events · 26 product records · 2010–2025 · FL

Medtronic Xomed, Inc. has 17 FDA enforcement events on this register (26 product records) between 2010 and 2025: 17 device; the busiest year was 2013 with 3.

18% of its events are Class I; the most common class is Class II (14). 10 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
17 Jul 2025IPC 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 open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws,…DeviceClass II1Ongoing
10 Mar 2025NIM 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 NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154…DeviceClass II1Ongoing
5 Jul 2024Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069DeviceClass II1Ongoing
24 Jun 2024NIM 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 NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number:…DeviceClass I1Ongoing
7 Nov 2023NIM 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 PKDeviceClass II1Ongoing
3 May 2022NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2DeviceClass II2Ongoing
29 Apr 2022NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506DeviceClass I3Ongoing
22 Dec 2021NIM TRIVANTAGE EMG Endotracheal TubeDeviceClass II1Ongoing
15 Dec 2021Software 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 EC300DeviceClass II1Terminated
31 Aug 2021Medtronic 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) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x…DeviceClass II3Ongoing
12 Jun 2020Software 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.DeviceClass II1Terminated
13 Nov 2019Lamicel 20PK 3MM INTL Cervical dilatorDeviceClass II3Ongoing
28 Jun 2016NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.DeviceClass II1Terminated
23 Aug 2013Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.DeviceClass II1Terminated
9 Jul 2013Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.DeviceClass II1Terminated
4 Mar 2013REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal…DeviceClass I1Terminated
27 Sep 2010Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled…DeviceClass II3Terminated

By type and class

Device17
Class II14
Class I3

Class I: 18% of this firm's events; 18% of all events on the register.

Events by year

10
12
14
16
18
20
22
24
26
Enforcement events for Medtronic Xomed, Inc. by year initiated.

Questions and answers

How many FDA recalls has Medtronic Xomed, Inc. had?

17 enforcement events (26 product records) on this register, 2010–2025: 17 device.

Are any Medtronic Xomed, Inc. recalls ongoing?

10 events are listed as ongoing in the current openFDA export.

What class are Medtronic Xomed, Inc. recalls?

14 Class II, 3 Class I. 18% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.