CLASS I ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report
NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed
Medtronic Xomed is recalling NIM EMG Endotracheal Tube, Part Numbers: a), distributed nationwide in the US. The recall was initiated on 29 Apr 2022 and the FDA has classified it as Class I.
Check your package
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-1521-2022
- FDA event ID
- 90711
- Recalling firm
- Medtronic Xomed, Jacksonville, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 29 Apr 2022
- FDA classified
- 1 Sep 2022
- Reported
- 7 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2022 | Recall initiated by company | |
| 1 Sep 2022 | Classified by FDA | +125 days |
| 7 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Product as listed by the FDA
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
Where it was distributed
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
Questions about this recall
Why was it recalled?
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Which lots are affected?
a) REF 8229307J, UDI 00613994415462, ALL LOTS; b) REF 8229308J, UDI 00613994415431, ALL LOTS; c) REF 8229306J, UDI 00613994415455, ALL LOTS
Where was it sold?
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
2 other products · FDA event 90711This product is part of a recall event; the main page for the event is NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed | Medtronic Xomed | Other | Nationwide | |
| CLASS I | NIM Contact EMG Endotracheal Tube, Part Numbers: a) recalled | Medtronic Xomed | Other | Nationwide |
More recalls from Medtronic Xomed
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|---|---|---|---|---|---|
| Device | CLASS II | IPC Powerease System recalled by Medtronic Xomed | Medtronic Xomed | Other | 25 states |
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| Device | CLASS II | NIM TriVantage EMG Endotracheal Tubes recalled by Medtronic Xomed | Medtronic Xomed | Other | FL |
| Device | CLASS I | NIM Contact EMG Endotracheal Tube, Part Numbers: a) recalled | Medtronic Xomed | Other | Nationwide |
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