HIGH

Medline Recalls Neuro Shunt Kits Over Sterility Concerns

Medline Industries recalled 7,494 neuro shunt kits on January 7, 2026, due to sterilization calibration issues. These problems could compromise the sterility assurance level of the products. Patients and healthcare providers should stop using the affected devices immediately.

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

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

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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

  1. Check the model number on the device packaging.
  2. Refer to the recall notice for a complete list of affected models.
  3. 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.

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.
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeNeuro Shunt Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
1) CDS860018G
UDI-DI: 10889942459643(each)
40889942459644(case)
Lot Number: 23CMH970
2) CDS860018G
+7 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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