Recall StatusOpen, Classified
Date Initiated2026-06-17
Product Quantity167
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.
Firm Action
On 6/17/2026, recall notices were mailed and emailed to customers asking them to do the following:
1) Identify, quarantine, and return affected devices to the firm.
2) Complete and return the Customer Confirmation Form via email to
[email protected]
3) This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.
For additional information, email the firm at
[email protected]
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.