Advanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution
Advanced Sterilization Products is recalling CIDEX Activated Dialdehyde Solution because it may lack adequate data to support its 24-month shelf life.
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 lack of data supporting shelf life without reporting any illnesses or injuries, fitting the criteria for a voluntary precautionary recall or minor labeling/data error.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266. The recall involves 23,426 cases distributed nationwide in the United States.
The product is being recalled because it may lack the adequate data to support the entire 24-month shelf life. The source text does not specify any reported illnesses, injuries, or specific adverse events associated with the use of this product.
Consumers and healthcare facilities should check their inventory for the affected product codes listed in the official recall notice. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 23,426
Distribution
Distributed nationwide across the United States.
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