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
- Neuro Shunt Kits
- Model numbers
- 1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970, 2) CDS860018G, Lot Number: 23CMD444, 3) CDS860018G, Lot Number: 23AMJ086 +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 neuro shunt kits are used in surgical procedures to manage cerebrospinal fluid and treat conditions such as hydrocephalus. These kits are essential for neurosurgeons and are typically used in hospitals or surgical centers.
Why This Is Dangerous
Calibration issues with sterilization equipment may compromise the sterility of the neuro shunt kits. If the kits are not properly sterilized, they may pose a risk of infection to patients upon use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a significant health risk as patients using these devices could face severe health complications. Healthcare providers must act quickly to remove these kits from use.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device packaging.
- Refer to the recall notice for a complete list of affected models.
- Contact Medline for verification if unsure.
Where to find product info
Model numbers are typically located on the product label or packaging.
What timeline to expect
Expect processing for refunds or returns to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with Medline regarding the recall.
- Follow up via phone or email if no response is received.
How to prevent similar issues
- When purchasing medical devices, ensure they come with clear sterilization certifications.
- Always check for recent recalls on medical products before use.
- Consult healthcare professionals about device safety.
Documentation advice
Keep a record of the recall notice, any correspondence with Medline, and receipts if available.
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Product Details
The recall affects various models of Medline neuro shunt kits, including CDS860018G and CDS860018I. These products were distributed worldwide, including throughout the U.S., and were sold in unspecified quantities. The products were exposed to validated sterilization cycles but failed to meet sterility assurance standards.
Key Facts
- Recall date: January 7, 2026
- Total units recalled: 7,494
- Class II recall due to sterility concerns
- Distribution: Worldwide, including U.S.
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Safety Guide
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