Medtronic endotracheal tubes recalled for reported airway obstruction risk
Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.
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 requires a minimum severity score of 4. The reported airway obstruction hazard in critical airway management devices justifies the Severe rating. No deaths or specific serious injuries are mentioned in the source, so the score does not reach Critical.
Plain-English summary
Medtronic Xomed, Inc. is recalling the NIM CONTACT EMG Endotracheal Tube in three part numbers (8229508, 8229507, 8229506) due to reports of airway obstruction during use. These tubes are used in anesthesia and critical care settings. The recall affects 81,555 units distributed worldwide, including throughout the United States and over 40 countries.
The company received reports of events related to airway obstruction while using these endotracheal tubes. This is a critical safety concern because endotracheal tubes are essential for maintaining open airways during medical procedures.
Healthcare facilities and providers currently using these specific part numbers should immediately stop using them and quarantine remaining stock. Affected tubes should not be used for any patient. Contact Medtronic Xomed or the FDA if you have questions or have experienced adverse events with these products.
The recalled product
- Product
- NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
- Manufacturer
- Medtronic Xomed, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 81,555
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 (13)
- a) REF 8229508
- UDI 00643169789579
- 00763000745868
- 00763000882433
- ALL LOTS. b) REF 8229507
- UDI 00643169789562
- 00763000745851
- 00763000882426
- ALL LOTS. c) REF 8229506
- UDI 00643169789555
- 00763000745844
- 00763000882419
- 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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