FDA Device recall Z-0978-2025
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only by Integra Lifesciences, citing potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0978-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-16 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Identifiers
| code_info | UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Integra Lifesciences
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FDA Device · Class II · 2025-02-19 · Integra Lifesciences - CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only
FDA Device · Class II · 2025-01-29 · Integra Lifesciences - CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
FDA Device · Class II · 2025-01-29 · Integra Lifesciences - SURG STRP 1/4X6 Model/Catalog Number: 801450
FDA Device · Class II · 2024-11-06 · Integra Lifesciences
All Integra Lifesciences recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0978-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.