Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation 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 hazard involves manufacturing defects (rips, holes, foreign material) that compromise barrier protection. No injuries or illnesses are reported, and the risk is theoretical rather than immediate physical harm like fire or choking, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 29,810,665 units of Lab Coats SMS Large Blue (SKU 2202LC) and Kendall Gowns. The recall covers all lot numbers from 18KXBXXXXX to 20KXBXXXXX. These products 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.
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 and lab coats. These defects may compromise the integrity of the barrier protection intended for use in healthcare settings.
The affected products were distributed globally, including nationwide in the United States (all 50 states, DC, and Puerto Rico) and in several international countries including Australia, Canada, Chile, Israel, Japan, the Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland, and the United Arab Emirates. Health care facilities and consumers should stop using the affected products and contact Cardinal Health for further instructions.
The recalled product
- Product
- Lab Coats SMS Large Blue, SKU 2202LC 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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