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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
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
- Review the model number on the product packaging
- Check for the lot number on the product
- 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
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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