NIM EMG Endotracheal Tubes recalled for risk of airway obstruction
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates a serious health hazard. Airway obstruction presents a significant injury risk in critical airway management devices, though no deaths or hospitalizations are explicitly reported in the source.
Plain-English summary
Medtronic Xomed, Inc. is recalling NIM EMG Endotracheal Tubes (part numbers 8229307J, 8229308J, and 8229306J). These are reinforced endotracheal tubes used during surgical procedures and in critical care settings.
The firm initiated this recall after receiving reports of airway obstruction occurring during use of the NIM Standard Reinforced EMG Endotracheal Tubes and the NIM CONTACT Reinforced EMG Endotracheal Tubes. The recall affects 23,820 units that were distributed worldwide, including throughout the United States and to over 60 international countries.
Healthcare providers and medical facilities using these devices should contact Medtronic Xomed immediately for further information and guidance regarding this recall.
The recalled product
- Product
- NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- Affected units
- 23,820
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 (7)
- a) REF 8229307J
- UDI 00613994415462
- ALL LOTS
- b) REF 8229308J
- UDI 00613994415431
- c) REF 8229306J
- UDI 00613994415455
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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