The Recall Desk
ModerateFDA (Devices)·Z-1090-2021·Announced 2021-02-17

Cardinal Health Recalls Lab Coats and Gowns Due to Defects

Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material.

What this means for you

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 describes potential defects (rips, holes, foreign material) without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health 200, LLC is recalling approximately 29,810,665 units of Lab Coats SMS X-Large Blue (SKU 2203LC), Cardinal Health Isolation Gowns, and Kendall Gowns. 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 where minimal fluid settings are expected.

The recall is being conducted 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. The affected lot numbers range from 18KXBXXXXX to 20KXBXXXXX.

The products were distributed globally, including nationwide in the United States and in specific countries such as 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 X-Large Blue, SKU 2203LC 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 mat
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Personal Protective Equipment
Hazard
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

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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.

See all 13 products in this recall →

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