HIGH

Medline Recalls Convenience Kits Due to Sterility Risks

Medline Industries recalled 1,496 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects various models, potentially compromising sterility assurance levels. Patients and healthcare providers must stop using these devices 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 designed for surgical procedures and include various tools and devices necessary for operations. Healthcare providers use these kits to ensure sterile conditions during surgeries and procedures.

Why This Is Dangerous

Calibration issues with sterilization equipment may compromise the sterility of the kits, potentially exposing patients to infection risks. Each kit was exposed to validated sterilization cycles, but the calibration errors raise concerns about their effectiveness.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare providers who rely on these kits. It may lead to delays in surgical procedures and requires immediate action to ensure patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the product packaging.
  2. Confirm if your product matches any of the recalled models listed in the recall notice.
  3. Look for any notifications from Medline in your mail or email.

Where to find product info

Model numbers can be found on the packaging or the product itself, typically near the barcode or on an attached label.

What timeline to expect

Expect a timeline of approximately 4-6 weeks for processing refunds or replacements after returning the product.

If the manufacturer is unresponsive

  • Contact Medline's customer service again for follow-up.
  • Keep a record of your communication attempts.
  • Consider filing a complaint with the FDA if you do not receive a response.

How to prevent similar issues

  • Always check for the latest recalls before using medical devices.
  • Look for products with clear labeling and safety certifications.
  • Consult with healthcare providers about the safety of medical products.

Documentation advice

Keep records of your purchase, any correspondence with Medline, and photographs of the product for your records.

Product Details

The recall includes the following models: DYKM1801B, DYKM1776, DYKM1765A, DYKM1796A, DYKM1756A, among others. The products were distributed worldwide, including the US. No pricing information was provided.

Key Facts

  • Recall date: January 7, 2026
  • Quantity recalled: 1,496 units
  • Class II recall
  • Potential sterility risks identified
  • Worldwide distribution
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeConvenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
1) DYKM1801B
UDI-DI: 10653160360421(each)
00653160360424(case)
Lot Number: 2024100790
2) DYKM1776
+15 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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