Medtronic Neurosurgery recalls Ventriculostomy Kit REF 461: endotoxin levels may exceed safe limits for cerebrospinal fluid contact, causing inflammation. Affected units sold with UDI-DI 00673978947396 and Lot 2025-08779.
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.
✎ GovInfoNow plain-language explainer
Medtronic Neurosurgery is recalling Ventriculostomy Kits with reference number 46154 due to potential endotoxin levels that could cause inflammation when used in cerebrospinal fluid. This risk applies to medical procedures where the device contacts cerebrospinal fluid. Read more at govinfonow.com/recall/127768-medtronic-neurosurgery-ventriculostomy-kit-recall-endotoxin-risk.
“Medtronic Neurosurgery Ventriculostomy Kit Recall: Endotoxin Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127768-medtronic-neurosurgery-ventriculostomy-kit-recall-endotoxin-risk. Based on FDA recall #Z-2768-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2768-2026%22&limit=1).
The FDA announced on June 17, 2026, that Medtronic Neurosurgery is recalling Ventriculostomy Kits (REF: 46154) due to potential endotoxin levels exceeding acceptable limits. The agency classified the Class II recall as voluntary and ongoing.
How to tell if you have it
Brand: Medtronic Neurosurgery
Product: Ventriculostomy Kit, REF: 46154
UDI-DI: 00673978947396
Lot: 2025-08779
Distribution: US states of UT, AL, CA, NC, GA, AR, LA, KY, IL, OK and Costa Rica
The hazard
The devices may exhibit endotoxin levels that exceed the acceptable limit for devices contacting cerebrospinal fluid. Endotoxin exposure can cause an acute inflammatory process.
Context
GovInfoNow's records show Medtronic Neurosurgery has 9 other recalls on record since December 20, 2017. Other recent recalls of similar products include Becker External Drainage System (November 1, 2024), Medtronic Duet Drainage System (January 22, 2024 and June 28, 2023), Medline Medical Kits Recall (July 8, 2026), and Medline Spinal Fusion Kits Recall (March 19, 2026).
How to tell if you have this one
Check for the reference number 46154 on the kit. Affected units include those with UDI-DI 00673978947396 and Lot number 2025-08779.
Brand
Medtr: Neurosurgery
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the reference number 46154 and UDI-DI 00673978947396 with lot number 2025-08779.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Georgia, Illinois, Kentucky, Louisiana, North Carolina, Oklahoma, Utah.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2768-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2768-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.