Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 29, 2026

Ventriculostomy Kit, REF: 46154

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Ventriculostomy Kit, REF: 46154

Identifiers to compare

  • UDI 00673978947396
  • Lot 2025-08779
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Ventriculostomy Kit, REF: 46154UDI-DI: 00673978947396, Lot: 2025-08779167Z-2768-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.