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 Convenience Kits
- Model numbers
- 1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191, 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199 +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's surgical convenience kits are used in various types of surgeries, providing essential tools and supplies. These kits are designed to streamline surgical procedures and improve efficiency in healthcare settings.
Why This Is Dangerous
The calibration issues identified may lead to compromised sterility levels, increasing the risk of infection for patients during surgical procedures. Sterility is crucial in medical settings to prevent post-operative complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Failure to address the recall can lead to serious health risks for patients, including potential infections, which can complicate recovery and extend hospital stays.
Practical Guidance
How to identify if yours is affected
- Check the model number on your surgical kit packaging or device.
- Compare it against the list of recalled model numbers provided by Medline.
- Look for any lot numbers mentioned in the recall notice.
Where to find product info
Model numbers and lot numbers are typically found on the packaging or the product label itself.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Medline customer service again for follow-up.
- Document all correspondence and attempts to reach out.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Always verify the sterility of surgical kits before use.
- Look for certifications on medical products indicating compliance with safety standards.
- Consult healthcare providers about the safety of medical devices before use.
Documentation advice
Keep all receipts, correspondence, and photos of the recalled product as records for your claims.
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Product Details
The recall affects multiple models, including CDS840015AQ, CDS840023T, and CDS840087AI. These products were distributed worldwide, including across the U.S. The kits are used in various surgical procedures.
Key Facts
- Calibration issues in sterilization equipment
- Risk of compromised sterility assurance level (SAL)
- 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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