HIGH

Medline Convenience Kits Recalled Over Sterility Issues

Medline recalled 5,346 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers, potentially compromising their sterility assurance. Healthcare providers and patients must stop using the products immediately.

Quick Facts at a Glance

Recall Date
January 7, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

Medline convenience kits are medical device packages designed for various healthcare procedures, including central line insertions and other sterile applications. Healthcare providers use these kits to ensure a sterile environment during procedures.

Why This Is Dangerous

Calibration issues with the sterilization equipment may lead to inadequate sterilization of the devices, increasing the risk of potential infections if used on patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using these devices immediately to avoid any risk of infection. The recall may cause inconvenience in medical settings, requiring alternative products.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number and lot number on your convenience kit packaging.
  2. Compare the model numbers against the list provided in the recall notice.
  3. If your product matches any of the recalled model numbers, stop using it immediately.

Where to find product info

Model numbers and lot numbers can typically be found on the packaging or attached labels of the kits.

What timeline to expect

Expect refund processing to take approximately 4-6 weeks after returning the product to Medline.

If the manufacturer is unresponsive

  • Document all communication attempts with Medline.
  • Contact your healthcare provider for additional support in resolving the issue.
  • Consider filing a complaint with the FDA if the response is inadequate.

How to prevent similar issues

  • Always purchase medical devices from reputable suppliers.
  • Check the FDA website regularly for safety alerts and recalls.
  • Ensure that products are certified for safety and sterility before use.

Documentation advice

Keep a record of the recall notice, any correspondence with Medline, and receipts or proof of purchase for your records.

Product Details

The recall includes 24 specific models, such as the PICC LINE TRAY (Model Number: 00-401993O) and CODE CART ADULT 4 CENTRAL LINE (Model Numbers: ACC010268B and ACC010268C). These kits were distributed worldwide, including throughout the United States.

Key Facts

  • Recall date: January 7, 2026
  • Reported date: February 25, 2026
  • Quantity recalled: 5,346 units
  • Distribution: Worldwide
  • Class II recall
View Original Recall on FDA - Medical Devices

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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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeConvenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
1) 00-401993O
UDI-DI: 10195327517366(each)
40195327517367(case)
Lot Number: 23KBH528
2) ACC010268B
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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