HIGH

Medline Recalls Convenience Kits Over Sterility Concerns

Medline Industries recalled 3,561 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple models, including the ENDO KIT W/SYRINGE and ANGIOGRAPHY PACK. Health providers should stop using these 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 surgical supplies used in various medical procedures. Healthcare providers purchase these kits for efficient and sterile operations.

Why This Is Dangerous

The sterilization calibration issues may compromise the sterility of the kits, increasing the risk of infections for patients when used in medical settings.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using these kits to avoid potential infections, which could lead to serious health complications.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers against the recall list.
  2. Look for lot numbers listed in the recall notice.
  3. Verify UDI-DI codes if available.

Where to find product info

Model numbers and lot numbers are typically located on the packaging or labels of the kits.

What timeline to expect

Expect a refund or replacement within 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document your correspondence with Medline.
  • Reach out to the FDA for further assistance if necessary.
  • Consider filing a complaint with the CPSC for unresolved issues.

How to prevent similar issues

  • Always check for recalls before purchasing medical supplies.
  • Look for certifications indicating proper sterilization standards.
  • Purchase from reputable suppliers with clear product labeling.

Documentation advice

Keep records of your purchase, including receipts and any correspondence with Medline regarding the recall.

Product Details

The recalled convenience kits include the following models: DYKE1743, DYNJ0800934D, DYNJ0842873J, DYNJ43415C, DYNJ44066A, DYNJ61978A, DYNJ63542B, DYNJ907452, DYNJC2371G, and PHS853965G. These products were distributed worldwide, including nationwide in the US.

Key Facts

  • Recall date: January 7, 2026
  • Total units recalled: 3,561
  • Class II recall due to high hazard level
  • Distribution: Worldwide
  • Immediate action required for healthcare providers

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
1) DYKE1743
UDI-DI: 10193489294606(each)
40193489294607(case)
Lot Number: 23KBQ544
2) DYKE1743
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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