NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Indi...

FDA Device Recall #Z-0901-2017 — Class II — June 28, 2016

Recall Summary

Recall Number Z-0901-2017
Classification Class II — Moderate risk
Date Initiated June 28, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Xomed, Inc.
Location Jacksonville, FL
Product Type Devices
Quantity 3752

Product Description

NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.

Reason for Recall

Wire in tubing can become exposed, posing potential harm to the intubated patient.

Distribution Pattern

Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand

Lot / Code Information

All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;

Other Recalls from Medtronic Xomed, Inc.

Recall # Classification Product Date
Z-2461-2025 Class II IPC Powerease System REF 2300000 UDI-DI: 0061... Jul 17, 2025
Z-1623-2025 Class II NIM Vital Nerve Monitoring System: CONSOLE NIM... Mar 10, 2025
Z-3130-2024 Class II Medtronic ENT Ultra Round Steel Cutting Bur, Mo... Jul 5, 2024
Z-2409-2024 Class I NIM Vital Nerve Monitoring systems (all serial ... Jun 24, 2024
Z-0696-2024 Class II NIM TriVantage EMG Endotracheal Tubes, Model (R... Nov 7, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.