Teleflex Recalls RUSCH Endotracheal Tubes for Cuff Diameter Labeling Error
Teleflex is recalling RUSCH Curved Reinforced Endotracheal Tubes because the labeled cuff diameter does not match the actual cuff diameter, though the actual product meets specifications.
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, but the source explicitly states that the actual product meets required specifications and the issue is a labeling discrepancy. This aligns with the rubric for minor labeling errors or low-risk issues where the product itself is not defective in a way that causes harm.
Plain-English summary
Teleflex, Inc. has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube. The recall is due to a discrepancy between the labeled cuff diameter and the actual cuff diameter of the device. The source text confirms that the actual product cuff diameter meets required specifications.
The affected product is designated for oral or nasal intubation and is indicated for airway management. It is intended to reduce the potential for kinking when unusual positioning of the head or neck is required following intubation. The recall covers 2,292,361 units that were distributed nationwide.
Healthcare facilities and consumers should verify the cuff diameter of their RUSCH Curved Reinforced Endotracheal Tubes against the labeling. Since the actual product meets required specifications, the hazard is limited to the labeling discrepancy. Users should consult the manufacturer or FDA for specific instructions on handling the affected lots.
The recalled product
- Product
- R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is…
- Manufacturer
- Teleflex, Inc.
- Hazard
- Affected units
- 2,292,361
Distribution
Distributed nationwide across the United States.
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