Integra LifeSciences Corp.: Medical Device Recall in 2025 - (Recall #: Z-0978-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 16, 2024

Date Posted: January 29, 2025

Recall Number: Z-0978-2025

Event ID: 95951

Reason for Recall:

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

Status: Ongoing

Product Quantity: 170 units

Code Information:

UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.

Distribution Pattern:

US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.

Voluntary or Mandated:

Voluntary: Firm initiated