The Recall Desk

FDA (Devices) recall action 95951

Integra LifeSciences Corp. recalled 3 products on 2025-01-29

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-01-29
Critical
0
Units
348

Why these products were recalled

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2025-01-29

    CODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions

    Integra LifeSciences is recalling 46 units of the CODMAN CERTAS Plus Programmable Valve due to incorrect product descriptions on internal and external labels. The affected devices were distributed nationwide across the U.S. and internationally.

    Product
    CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2025-01-29

    Programmable Valve Device Recalled Due to Incorrect Product Description Labels

    CODMAN CERTAS Plus Programmable Valve (Model 828810) units were distributed with incorrect product descriptions on labels. 132 units affected across multiple U.S. states and international locations.

    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.
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2025-01-29

    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.

    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.
    Category
    Distribution
    22 states