FDA Medical devices recall ·
Ventriculostomy Kit recall
- Recall number
- Z-2768-2026
- Date
- (initiated June 17, 2026)
- Company / brand
- Medtronic Neurosurgery
4620 N Beach St, Haltom City, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 167
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ventriculostomy Kit, REF: 46154
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00673978947396, Lot: 2025-08779
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: Alabama Arkansas California Georgia Illinois Kentucky Louisiana North Carolina Oklahoma Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2768-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.