Teleflex Medical Recalls Hudson RCI ConchaTherm Neptune Heated Humidifiers
Teleflex Medical is recalling 7,228 Hudson RCI ConchaTherm Neptune Heated Humidifiers because customer complaints reported the power ceasing and the display going blank.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (power loss) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Teleflex Medical is recalling 7,228 units of the Hudson RCI ConchaTherm Neptune Heated Humidifier, a prescription-only medical device. The recall was initiated after the company received customer complaints stating that power to the unit ceased and the display went blank.
The affected devices were distributed nationwide in the United States and internationally to Belgium and Japan. The specific units are identified by material number 425-00 and a long list of serial numbers provided in the official recall documentation.
Consumers and healthcare facilities should check their inventory for the affected serial numbers. If a device is found to be part of this recall, users should contact Teleflex Medical for instructions on how to proceed with the recall action.
The recalled product
- Product
- Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 7,228
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 (20)
- Material number: 425-00
- Serial numbers: 611040101
- 611040106
- 611040107
- 611040108
- 611040109
- 611040110
- 611040111
- 611040113
- 611040114
- 611040117
- 611040118
- 611040119
- 611040120
- 611050001
- 611050002
- 611050004
- 611050005
- 611050008
- 611050010
Distribution
Distributed nationwide across the United States.
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