Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (barrier protection failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 29.8 million units of Cardinal Health Isolation Gowns, Lab Coats, and Kendall Gowns. The recall involves specific SKUs including 1100PG, V1100PG, 2100PG, V2100PG, and 2150PG, covering lot numbers from 18KXBXXXXX to 20KXBXXXXX.
The FDA has classified this as a Class II recall because the product has a potential for rips, holes, tears, incomplete or open seams, staining, or foreign material. These defects could reduce the gown's ability to provide minimal barrier protection against microorganisms, body fluids, and particulate material for health care patients and personnel.
The affected products were distributed nationwide in the United States, including Puerto Rico, and internationally to Australia, Canada, Chile, Israel, Japan, the Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland, and the United Arab Emirates. Health care facilities should stop using the affected gowns and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG 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
- 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.
See all 13 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighCardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
Same hazard · defective manufacturing
See all →- HighOMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality
FDA (Devices) · 2023-11-01
- ModerateCardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects
FDA (Devices) · 2021-02-17
- HighPaltop Advanced Plus Dental Implant Recall for Surface Topography Defects
FDA (Devices) · 2019-10-09
- HighSenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency
FDA (Devices) · 2019-08-14
- HighSenTec Membrane Changer Insert Recalled for Electrolyte Application Defect
FDA (Devices) · 2019-08-14