Cardinal Health Recalls Kendall Blue XXL Gowns Due to Defects
Cardinal Health is recalling Kendall Blue XXL gowns due to potential rips, holes, or 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 defects (rips, holes, foreign material) represent a potential failure of barrier protection without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 29,810,665 units of Kendall Blue XXL gowns (SKU CT5102). These 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 material where minimal fluid settings are expected.
The recall was initiated because there is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris on the gowns. These defects may compromise the integrity of the barrier protection.
The affected products were distributed globally, including nationwide in the United States and in several international countries. All lot numbers from 1901XXK to 2010XXK are included in this recall. Health care facilities and consumers should stop using these gowns and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- Gown Kendall Blue XXL, SKU CT5102 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 1901XXK to 2010XXK
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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