FDAFDA · Food and drugs·Recall number Z-2768-2026
Ventriculostomy Kit, REF: 46154
Published July 29, 2026 · Recall initiated: June 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neurosurgery
- Distributor
- Worldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA, AR, LA, KY, LA, KY, IL, OK and the country of Costa Rica.
- Lot
- UDI-DI: 00673978947396, Lot: 2025-08779
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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