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.
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 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…
- 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 →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
Same hazard · foreign material
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- ModerateSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk Recalled for Foreign Material
FDA (Food) · 2026-09-30
- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Similar recalls
- HighCardinal Health Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect
FDA (Devices) · 2021-12-22
- HighCardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals
FDA (Devices) · 2021-12-22
- HighCardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals
FDA (Devices) · 2021-12-22
- HighRoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22