Adept Medical recalls silicone T-Tube 12mm (Product Code NZ3312) due to lack of 510(k) clearance. Affected units sold from 2008-2023; consumers should contact the company for details.
Lack of 510(k) clearance.
Adept Medical is recalling silicone T-Tube 12mm devices (Product Code NZ3312) because they lack FDA 510(k) clearance. This means the product may not be safe for medical use, though the recall does not specify immediate risks.
The product lacks FDA 510(k) clearance, which is required for medical devices to be safe and effective. Without this clearance, the device may not meet safety standards, potentially causing harm during medical procedures.
Patients using the T-Tube 12mm silicone device for ear ventilation are likely affected. Medical professionals who have purchased these devices for clinical use may also be impacted.
Check for the product code NZ3312 on the device packaging or label. Units with lot numbers from 2008-1461 through 2023-10966 are affected.
Identify the product code NZ3312 and lot numbers listed in the recall notice to confirm if your device is affected.
The product lacks FDA 510(k) clearance, which is required for medical devices to be safe and effective.
Contact Adept Medical directly to confirm if your device is affected and follow their instructions.
The recall does not specify immediate risks, but the lack of 510(k) clearance means the device may not meet safety standards.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0967-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0967-2025 from Adept Medical. 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.
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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.
