HIGH

Medline Recalls Convenience Kits Due to Sterility Concerns

Medline Industries, LP recalled 551 units of convenience kits on January 7, 2026. Calibration issues in sterilization equipment may affect product sterility. Healthcare providers and patients must stop using the kits 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 pre-packaged sets of medical devices used in various healthcare settings to facilitate procedures. They are designed for quick and easy access to necessary tools during surgeries and other medical interventions.

Why This Is Dangerous

Calibration issues in the sterilization equipment may lead to insufficient sterility assurance, potentially allowing pathogens to survive on the devices. This increases the risk of infection for patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall necessitates immediate action from healthcare providers to ensure patient safety, potentially disrupting medical procedures. It emphasizes the importance of product sterility in medical devices.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the product packaging.
  2. Verify lot numbers against the recall notice.
  3. Contact Medline if there are uncertainties about your product.

Where to find product info

Model and lot numbers can typically be found on the packaging or the product itself, often near the barcode or on a label attached to the device.

What timeline to expect

Expect refund processing to take approximately 4-6 weeks after contacting Medline for instructions.

If the manufacturer is unresponsive

  • Document your attempts to contact Medline.
  • Follow up with a letter detailing your concerns and request for assistance.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Always check for recent recalls before using medical devices.
  • Ensure products are from reputable manufacturers with good safety records.
  • Look for certifications indicating products meet safety standards.

Documentation advice

Keep records of all communications with Medline, including dates, times, and details of your requests. Maintain copies of receipts or proof of purchase if available.

Product Details

The recall affects two models: ANCILLARY PACK-LF (Model Number: DYNJ0185290G) and OPEN HEART ANESTHESIA ICC-A (Model Number: DYNJ905567A). These products were distributed worldwide, including across the U.S. No specific price was mentioned.

Key Facts

  • Recall date: January 7, 2026
  • Quantity recalled: 551 units
  • Risk level: High
  • Distribution: Worldwide
  • No reported injuries or deaths
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) DYNJ0185290G
UDI-DI: 10193489378054(each)
40193489378055(case)
Lot Number: 22LBQ336
2) DYNJ905567A
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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