Official recall notice
FDA DeviceClass IINotable
FDA Recall: Ventriculostomy Kit, REF: 46154
- Recall date
- 2026-07-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
UDI-DI: 00673978947396, Lot: 2025-08779