Integra LifeSciences CODMAN CERTAS Plus Valve Recall: Incorrect Labeling Risk
Integra LifeSciences recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve (Model 828810) due to incorrect labeling on some SKUs and lot numbers. Affected units may have wrong product descriptions on internal and external labels.
Lower-risk recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling certain CODMAN CERTAS Plus Programmable Valve Inline Small Valves (Model 828810) because some units have incorrect product descriptions on both internal and external labels. This labeling issue could lead to confusion about the device's intended use, potentially affecting patient safety. Read more at govinfonow.com/recall/53289-integra-lifesciences-codman-certas-plus-valve-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53289-integra-lifesciences-codman-certas-plus-valve-recall-incorrect-labeling-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0977-2025
Cite this page
“Integra LifeSciences CODMAN CERTAS Plus Valve Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53289-integra-lifesciences-codman-certas-plus-valve-recall-incorrect-labeling-risk. Based on FDA recall #Z-0977-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0977-2025%22&limit=1).
Why it’s dangerous
The device has incorrect product descriptions on both internal and external labels for specific lot numbers. This labeling error could cause confusion about the device's intended use, which might impact patient safety if the wrong device is used in treatment.
Who’s affected
Patients who have received the CODMAN CERTAS Plus Programmable Valve Inline Small Valve (Model 828810) with lot numbers 7432470, 7434917, 7434918, or 7438322 are most at risk. Healthcare providers who use this device should verify the labels.
How to tell if you have this one
Check for the model number 828810 and lot numbers 7432470, 7434917, 7434918, or 7438322 on the device's internal and external labels.
- Brand
Integra LifeSciences- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0977-2025 | 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.; UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322. | 132 units |
| Z-0978-2025 | 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.; UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313. | 170 units |
| Z-0979-2025 | 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.; UDI-DI: 10381780535997. Lot Number: 7415567. | 46 units |
What to do — step by step
Check Labels
Verify the model number and lot numbers on the device's internal and external labels.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0977-2025 (December 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0977-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.