Medtronic endotracheal tubes recalled due to manufacturing nonconformity
Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing nonconformity in a critical airway medical device. The source describes a risk-of-harm product with no reported injuries or illnesses, meeting the criteria for High severity.
Plain-English summary
Medtronic Xomed, Inc. is recalling the NIM TRIVANTAGE EMG Endotracheal Tube. The recall covers over 301,926 devices distributed across multiple product numbers.
The recall is due to a manufacturing nonconformity that could lead to multiple issues with these devices. The FDA classified this as a Class II recall.
The affected devices were distributed worldwide, including throughout the United States and to numerous countries across North America, South America, Europe, Asia, Africa, Australia, and the Middle East.
The recalled product
- Product
- NIM TRIVANTAGE EMG Endotracheal Tube
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- Affected units
- 301,926
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Products: 1) Product Number 8229705 (GTIN 00763000033934)
- Lots: 0218762694
- 0218663943
- 0219904500
- 0220293429
- 0220584798
- 0220756285
- 0220774358
- 0221736070
- 0221805033
- 0222186741
- 0222495993
- 0222591367 2) Product Number 8229706 (GTIN 00763000033941)
- Lots: 0218663944
- 0218664146
- 0218762695
- 0218762699
- 0218762698
- 0218762697
- 0219010138
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtronic Xomed, Inc.
See all →- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighMedtronic NIM Vital Nerve Monitoring System Software Version Recall
FDA (Devices) · 2025-04-30
- HighMedtronic ENT Surgical Cutting Bur Distributed Past Expiration Date
FDA (Devices) · 2024-09-18
- SevereNIM Vital Nerve Monitoring Systems Recalled for False Negative Risk
FDA (Devices) · 2024-07-31
- HighNIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring
FDA (Devices) · 2024-01-17
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- SevereNIM EMG Endotracheal Tubes recalled for risk of airway obstruction
FDA (Devices) · 2022-09-07
- HighNIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring
FDA (Devices) · 2024-01-17
- SevereMedtronic endotracheal tubes recalled for reported airway obstruction risk
FDA (Devices) · 2022-09-07
- HighMedtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard
FDA (Devices) · 2017-01-04
- SevereMedtronic Recalls NIM TriVantage EMG Endotracheal Tubes Due to Cuff Leakage
FDA (Devices) · 2013-06-12
- HighNeurovision Cobra x5 EMG Endotracheal Tubes Recalled for Insulation Defect
FDA (Devices) · 2020-09-02