FDAFDA recall Z-2768-2026 · Jul 29, 2026
Medtronic Neurosurgery: Ventriculostomy Kit recall
Recall found
Product
Ventriculostomy Kit, REF: 46154
Reason for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00673978947396, Lot: 2025-08779
- Quantity
- 167
- 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.
- Recalling firm
- Medtronic Neurosurgery, Haltom City, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-17
Source: openFDA enforcement record Z-2768-2026 · search recall number Z-2768-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.