Ventriculostomy Kit — Class II medical device recall Z-2768-2026
Ongoing recall by Medtronic Neurosurgery, reported 2026-07-29, distributed nationwide. Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may
| Recall number | Z-2768-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Haltom City, TX, United States |
| Recall initiated | 2026-06-17 |
| Classified | 2026-07-21 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR |
| Quantity | 167 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00673978947396 |
| Lot numbers | 2025-08779 |
| Model numbers | 46154 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2768-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.