Integra implantable hydrocephalus valve recalled for incorrect product description on labels
Integra LifeSciences is recalling CODMAN CERTAS Plus Programmable Valves (Model 828810PL) due to incorrect product descriptions on internal and external labels. The mislabeling affects 170 units distributed across the US and several international locations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification. The recall involves labeling errors—incorrect product descriptions on internal and external labels—with no reported illnesses or injuries. Labeling errors without reported harm constitute Moderate severity per the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only (Model 828810PL), an implantable device used to manage hydrocephalus by providing constant intraventricular pressure and drainage of cerebrospinal fluid (CSF). Approximately 170 units of this device were distributed with incorrect product descriptions on internal and external labels.
The affected devices were distributed in multiple U.S. states and internationally to Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia, and Great Britain. The recall involves lot numbers 7416790, 7432471, 7434929, 7434930, 7438312, and 7438313.
Patients who have received these devices or healthcare providers at facilities that distributed them should verify the correct product information and ensure accurate documentation of their medical records. Contact Integra LifeSciences Corp. for additional information about the recalled units.
The recalled product
- 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.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 10381780535881. Lot Numbers: 7416790
- 7432471
- 7434929
- 7434930
- 7438312 and 7438313.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03