FDA recall, , Moderate risk
Medtronic Ventriculostomy Kit
Ventriculostomy kits may have endotoxin levels above the acceptable limit, which can cause an acute inflammatory process.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Neurosurgery of Haltom City, Texas, began a recall of its Ventriculostomy Kit, REF 46154, on June 17, 2026, because the devices 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.
The recall was added to the FDA's Enforcement Report and classified on July 21, 2026. Distribution included US states such as Utah, Alabama, California, North Carolina, Georgia, Arkansas, Louisiana, Kentucky, Illinois, and Oklahoma, as well as Costa Rica.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Ventriculostomy Kit
- UDI-DI
- 00673978947396
- Reference number
- 46154
- Lot code
- 2025-08779
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Utah, Alabama, California, North Carolina, Georgia, Arkansas, Louisiana, Kentucky, Louisiana, Kentucky, Illinois, Oklahoma and the country of Costa Rica.
- Company
- Medtronic NeurosurgeryHaltom City, Texas
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99342
- Recall number
- Z-2768-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
