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All product recalls associated with DeVilbiss Healthcare LLC.
Total Recalls
3
Past Year
0
Class I (Serious)
0
Most Recent
Mar 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)