NIM EMG Endotracheal Tubes recalled for risk of airway obstruction
Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.
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: This is an FDA Class I recall, which mandates a minimum severity score of 4. The source reports events related to airway obstruction but does not specify reported deaths or hospitalizations, so the score is Severe (4) rather than Critical (5).
Plain-English summary
Medtronic Xomed, Inc. is recalling NIM EMG Endotracheal Tubes (Part Numbers 8229308, 8229307, and 8229306). These are medical devices used during anesthesia and airway management procedures.
The FDA has classified this as a Class I recall. The firm received reports of events related to airway obstruction while using these tubes. All lots of the affected part numbers are included in this recall.
Approximately 1.1 million units have been distributed worldwide, including throughout the United States and to countries across Europe, Asia, the Middle East, and other regions. Healthcare providers who have received these devices should take appropriate action based on guidance from Medtronic Xomed and their healthcare facility protocols.
The recalled product
- Product
- NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- Affected units
- 1,133,612
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 (14)
- a) REF 8229308
- UDI 00643169789548
- 00763000745837
- 00763000882402
- ALL LOTS. b) REF 8229307
- UDI 00643169789531
- 00763000745820
- 00763000882396
- ALL LOTS. c) REF 8229306
- UDI
- 00643169789524
- 00763000745813
- 00763000882389
- ALL LOTS.
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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