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Medline Recalls Convenience Kits Over Sterility Concerns

Medline recalled 553 units of its Convenience Kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must stop using the affected devices immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) DYKMBNDL130UDI-DI: 10193489479027(each)40193489479028(case)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 7, 2026
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Product type
Convenience Kits
Model numbers
1) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580, 2) DYKMBNDL130, Lot Number: 21ABJ543, 3) DYKMBNDL130, Lot Number: 21ABC197 +6 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 7, 2026

  2. Reported by FDA DEVICE

    February 25, 2026

  3. RecallRadar source check

    March 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

Medline Convenience Kits are designed for use in medical procedures, providing necessary sterile equipment and supplies. They are commonly used in hospitals and healthcare settings for various applications.

Why This Is Dangerous

The calibration issues with sterilization equipment may lead to inadequate sterilization of the products, increasing the risk of infection for patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall presents a high level of urgency for healthcare providers and patients, as using affected products may compromise patient safety.

Practical Guidance

How to identify if yours is affected

  1. Review the model number on the product packaging
  2. Check for the lot number on the product
  3. Confirm if your product is listed in the recall notice

Where to find product info

Model and lot numbers are usually found on the product packaging or product label.

What timeline to expect

Expect a refund or replacement processing time of 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Contact Medline customer service for assistance
  • Document all communications regarding the recall
  • File a complaint with the FDA if necessary

How to prevent similar issues

  • Always check for recalls on medical devices before purchase
  • Look for FDA approval and certifications for safety
  • Ensure the product's sterilization documentation is up to date

Documentation advice

Keep a record of all correspondence, receipts, and photographs of the product.

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Product Details

The recalled models include DYKMBNDL130, DYKMBNDL130A, DYKMBNDL4, LC295, DYKM1977C, and CVI4300. These products were distributed worldwide, including throughout the United States. No price information is available.

Key Facts

  • Models include DYKMBNDL130, DYKMBNDL130A, and others
  • Stop using affected products immediately
  • Contact Medline for further instructions

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) DYKMBNDL130
UDI-DI: 10193489479027(each)
40193489479028(case)
Lot Number: 21BBB580
2) DYKMBNDL130
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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