Medline Trach Tube Kit Recalled for Component Labeling Discrepancy
Medline is recalling 45 Trach Tube Kits (SKU DYKM2330) due to a component labeling discrepancy. The recall covers units distributed in California.
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 text explicitly states the issue is a 'component labeling discrepancy' and does not report any illnesses or injuries. Per the rubric, minor labeling errors without reported harm fall under Moderate severity.
Plain-English summary
Medline Industries, LP is recalling 45 units of the Medline medical convenience kit labeled as TRACH TUBE KIT (SKU DYKM2330). The recall is being conducted due to a component labeling discrepancy. The affected products are identified by UDI/DI 10198459582158 (each) and 40198459582159 (case), with Lot Number 26FLA408.
The recall covers units distributed in California. The source text does not specify the exact nature of the labeling error or report any illnesses or injuries associated with the product.
Consumers and healthcare facilities should check their inventory for the specific SKU and lot number listed above. If the product is found, it should be removed from use and returned to Medline or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 45
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 (2)
- UDI/DI 10198459582158 (each) 40198459582159 (case)
- Lot Number 26FLA408
Distribution
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