HIGH

Medline PPE Kits Recalled Due to Sterilization Issues

Medline Industries recalled 7,575 PPE kits on January 7, 2026, due to calibration problems affecting sterilization. The recall involves model number DYK1011945P, distributed worldwide. Users should stop using the affected kits immediately and follow manufacturer instructions.

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

The Medline Convenience Kits PPE Kit is designed for healthcare settings to provide personal protective equipment for staff and patients. Consumers purchase these kits to ensure safety during medical procedures and to prevent the spread of infections.

Why This Is Dangerous

Calibration issues in the sterilization equipment could lead to inadequately sterilized products, risking contamination and infection. This affects the overall safety of the PPE kits, which are critical for infection control in healthcare settings.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers and healthcare providers are urged to stop using the affected PPE kits immediately, as they may not provide the necessary protection against infections. The recall causes inconvenience and potential health risks.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on the packaging or product insert.
  2. Check the lot numbers listed in the recall notice against your product.
  3. If your product matches, it is affected by the recall.

Where to find product info

Model numbers and lot numbers are typically found on the product packaging or accompanying documentation.

What timeline to expect

Expect a refund or replacement process to take approximately 4-6 weeks from the date of return.

If the manufacturer is unresponsive

  • Document all communications with Medline Industries.
  • Follow up via email or phone if you do not receive a response within 2 weeks.
  • Consider filing a complaint with the CPSC if issues persist.

How to prevent similar issues

  • Always verify the sterility of medical devices before use.
  • Choose products from trusted manufacturers known for quality control.
  • Look for FDA clearance or approval on medical devices.

Documentation advice

Keep copies of your purchase receipts, correspondence with Medline, and any return shipping receipts.

Product Details

The recalled product is the Medline Convenience Kits PPE Kit, Model Number DYK1011945P. The kits were sold worldwide, including across the United States. The quantity recalled is 7,575 units.

Key Facts

  • Recall date: January 7, 2026
  • Model Number: DYK1011945P
  • Total units recalled: 7,575
  • Distribution: Worldwide
  • No reported injuries

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 Details

Model Numbers
1) DYK1011945P
UDI-DI: 10884389389973(each)
40884389389974(case)
Lot Number: 25IFA006
2) DYK1011945P
+7 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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