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.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
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.
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.
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.
Check for the model number 828810 and lot numbers 7432470, 7434917, 7434918, or 7438322 on the device's internal and external labels.
Verify the model number and lot numbers on the device's internal and external labels.
The model number is 828810.
Lot numbers 7432470, 7434917, 7434918, and 7438322 are affected.
Check for the model number 828810 and lot numbers 7432470, 7434917, 7434918, or 7438322 on the device's internal and external labels.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0977-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0977-2025 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
