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) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933, 2) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093 +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 medical device kits used in various healthcare procedures, designed to provide necessary tools for surgeries and other medical interventions. Healthcare providers rely on these kits for efficient and safe patient care.
Why This Is Dangerous
Calibration issues with the sterilization equipment may lead to compromised sterility, increasing the risk of infection or other health complications for patients. Proper sterility is critical for any medical device used in clinical settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects thousands of healthcare providers and patients who rely on these kits for safe medical procedures. The urgency to stop using these products is high due to the potential for serious health risks.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging of your Medline convenience kit.
- Cross-reference your model number with the list provided in the recall notice.
- Check for any additional identifiers, such as lot numbers, to confirm if your product is affected.
Where to find product info
Model numbers and lot numbers can typically be found on the packaging or printed labels attached to the product.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after submitting your request.
If the manufacturer is unresponsive
- Contact Medline Industries customer service directly for follow-up.
- Document your communications, including dates and names of representatives.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Verify product packaging for any signs of damage or improper sterilization.
- Ensure that all medical products have proper certification before purchase.
Documentation advice
Keep records of your purchase, including receipts and any correspondence regarding the recall for potential claims.
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Product Details
The recall involves various Medline convenience kits, including the OR Arteriogram (Model Number: CDS985094F) and additional kits for cardiac procedures. These products were distributed globally and are associated with potential sterility issues.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 30,958 units
- Class II recall due to potential sterility issues
- 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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