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
- Surgical Kits
- Model numbers
- 1) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172, 2) CDS860015U, Lot Number: 21LBD726, 3) CDS860015U, Lot Number: 21KBB595 +4 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 surgical kits contain essential instruments and supplies for various surgical procedures. Healthcare providers use these kits to ensure a comprehensive approach to patient care during surgeries.
Why This Is Dangerous
Calibration issues in sterilization equipment may lead to inadequate sterilization of surgical instruments, potentially allowing microorganisms to survive. This could result in infections for patients undergoing surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause delays in surgical procedures as healthcare providers must halt the use of affected kits. Patients may need to reschedule surgeries, leading to potential health risks.
Practical Guidance
How to identify if yours is affected
- Check the model number of your surgical kit against the recalled list.
- Inspect the packaging for any recall notices or updates.
- Consult your healthcare provider for confirmation of the recall.
Where to find product info
Model numbers are typically located on the packaging or instruction manual of the surgical kit.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Follow up with Medline Industries via phone or email if you do not receive a timely response.
- Document all interactions with the company for your records.
How to prevent similar issues
- Look for products that have recent quality certifications.
- Choose surgical kits from reputable manufacturers with a history of compliance.
- Verify sterility assurance levels before purchasing surgical supplies.
Documentation advice
Keep a record of your purchase, any correspondence with the manufacturer, and photos of the kit if applicable.
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Product Details
The recall affects a total of 82,597 units across multiple model numbers, including CDS860015U, CDS860016P, and CDS984244J. These products were distributed worldwide, including throughout the United States. No specific retail price was provided.
Key Facts
- Recall date: January 7, 2026
- Calibration issues with sterilization equipment
- Potential risk of infection due to compromised sterility
- No reported injuries or incidents
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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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