CLASS II Device recall · Reported 4 Jan 2017 · FDA Enforcement Report

NIM EMG Endotracheal Tube I.D recalled by Medtronic Xomed

Medtronic Xomed is recalling NIM EMG Endotracheal Tube I.D. x O.D., Reinforced, Sterile, distributed nationwide in the US. The recall was initiated on 28 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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;

Quantity recalled3752

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0901-2017
FDA event ID: 74834
Recalling firm: Medtronic Xomed, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 28 Jun 2016
FDA classified: 23 Dec 2016
Reported: 4 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Jun 2016	Recall initiated by company
23 Dec 2016	Classified by FDA	+178 days
4 Jan 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Xomed

All 25

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Device	CLASS II	IPC Powerease System recalled by Medtronic Xomed	Medtronic Xomed	Other	25 states
30 Apr 2025Device	CLASS II	NIM Vital Nerve Monitoring System: Console NIM4CM01 NIM recalled	Medtronic Xomed	Device Malfunction	Nationwide
18 Sep 2024Device	CLASS II	Medtronic ENT Ultra Round Steel Cutting Bur recalled by Medtronic Xomed	Medtronic Xomed	Other	FL
17 Jan 2024Device	CLASS II	NIM TriVantage EMG Endotracheal Tubes recalled by Medtronic Xomed	Medtronic Xomed	Other	FL
7 Sep 2022Device	CLASS I	NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed	Medtronic Xomed	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide