Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026

Ventriculostomy Kit, REF: 46154

Medtronic Neurosurgery

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neurosurgery · 4620 N Beach St · Haltom City, TX · 76137-3219

Is this the product you have?

  • Ventriculostomy Kit
  • REF46154
Lot codes and dates
  • UDI-DI00673978947396
  • Lot2025-08779
Amount recalled
167

Where it was sold

Why it was recalled

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 6:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.