CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only — Class II medical device recall Z-0977-2025
Ongoing recall by Integra LifeSciences Corp., reported 2025-01-29, distributed nationwide. Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the inte
| Recall number | Z-0977-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-12-16 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CY, FI, GB, NZ, SE, SI |
| Quantity | 132 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10381780535874 |
| Lot numbers | 7432470, 7434917, 7434918, 7438322 |
| Model numbers | 828810 |
Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason for recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
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-0977-2025. 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.