Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
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 explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 29,810,665 units of Lab Coats SMS Medium White (SKU 2301LC), Cardinal Health Isolation Gowns, and Kendall Gowns. The recall is due to a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris on the products. These defects may compromise the intended minimal barrier protection for health care patients and personnel against microorganisms, body fluids, and particulate material.
The affected products were distributed globally, including nationwide in the United States and in specific countries such as Australia, Canada, and Japan. The recall covers all lot numbers from 18KXBXXXXX to 20KXBXXXXX. No illnesses or injuries have been reported in connection with this recall.
Health care facilities and consumers should stop using the affected products and contact Cardinal Health for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 29,810,665
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 (1)
- All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Distribution
Part of a larger recall action
This product is one of 13 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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