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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Codman CERTAS Plus Programmable Valves Recalled for Incorrect Labeling

Agency Publication Date: January 17, 2025
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Summary

Integra LifeSciences Corp. is recalling approximately 348 Codman CERTAS Plus Programmable Valves because they were distributed with the incorrect product description on both the internal and external labels. These implantable devices are used to manage hydrocephalus by maintaining constant brain pressure and draining excess fluid. While no injuries or incidents have been reported, the labeling error could lead to the selection or use of the wrong valve during a medical procedure.

Risk

The incorrect product description on the labeling creates a risk that medical professionals may implant a valve that does not match the patient's needs. This could lead to improper drainage of brain fluid and potential complications for patients being treated for hydrocephalus.

What You Should Do

  1. This recall affects Codman CERTAS Plus Programmable Valves, specifically the Inline Small Valve (Models 828810 and 828810PL) and the Right Angle Valve (Model 828820).
  2. Check your inventory for lot numbers 7432470, 7434917, 7434918, 7438322, 7416790, 7432471, 7434929, 7434930, 7438312, 7438313, or 7415567.
  3. Stop using the recalled device immediately.
  4. Contact Integra LifeSciences Corp. or your medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  5. Call the FDA at 1-888-463-6332 for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
Model / REF:
828810
Lot Numbers:
7432470
7434917
7434918
7438322
UDI:
10381780535874

Recall #: Z-0977-2025; Quantity: 132 units

Product: CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
Model / REF:
828810PL
Lot Numbers:
7416790
7432471
7434929
7434930
7438312
7438313
UDI:
10381780535881

Recall #: Z-0978-2025; Quantity: 170 units

Product: CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only
Model / REF:
828820
Lot Numbers:
7415567
UDI:
10381780535997

Recall #: Z-0979-2025; Quantity: 46 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95951
Status: Active
Manufacturer: Integra LifeSciences Corp.
Sold By: Hospitals; Surgical centers; Medical distributors
Manufactured In: United States
Units Affected: 3 products (132 units; 170 units; 46 units)
Distributed To: Florida, North Carolina, Massachusetts, Minnesota, Ohio, District of Columbia, Virginia, California, Wisconsin, Nebraska, Texas, New York, Michigan, Oregon, New Jersey, South Carolina, Arizona, Utah, Rhode Island, Indiana, Georgia, Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.