HIGH

CareFusion Recalls ChloraPrep Swabsticks Due to Sterility Concerns

CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.

Quick Facts at a Glance

Recall Date
December 17, 2025
Hazard Level
HIGH
Brands
ChloraPrep, CareFusion
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Lack of Assurance of Sterlity

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CareFusion 213, LLC or your healthcare provider for guidance. Notification method: Letter

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About This Product

ChloraPrep Swabsticks are antiseptic applicators used to prepare skin for medical procedures by reducing bacteria. They are commonly used in healthcare settings and by individuals for minor procedures.

Why This Is Dangerous

The lack of assurance of sterility means the swabsticks may not effectively eliminate bacteria, increasing the risk of infection during medical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they have used the affected swabsticks. The recall requires immediate action to prevent potential infections.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the packaging: 5086623.
  2. Verify the expiration date: March 31, 2028.
  3. If both match, the product is recalled.

Where to find product info

Look for the lot number and expiration date printed on the swabstick packaging.

What timeline to expect

Expect a refund or replacement processing time of about 4-6 weeks.

If the manufacturer is unresponsive

  • Document your communication attempts with CareFusion.
  • Consider filing a complaint with the FDA if unresponsive.

How to prevent similar issues

  • Always check for recall information before using medical products.
  • Look for products with guaranteed sterility certifications.

Documentation advice

Keep all receipts, correspondence with CareFusion, and any medical records related to the use of the product.

Product Details

The recalled product is BD ChloraPrep Triple Swabsticks, containing Chlorhexidine gluconate (2% w/v) and Isopropyl alcohol (70% v/v). The lot number is 5086623 with an expiration date of March 31, 2028. The swabsticks were distributed nationwide in the United States.

Key Facts

  • 106,400 units recalled
  • Risk of infection due to sterility issues
  • Stop using product immediately
  • Contact CareFusion for more information
  • Distributed nationwide in the U.S.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: 5086623
Exp. Date 03/31/2028
UPC Codes
54365-401
54365-401-28
54365-401-29
Affected States
ALL
Report Date
January 7, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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