Adept Medical recalls T-Tube 12mm silicone ventilation tubes due to lack of 510(k) clearance. Consumers should check product codes and serial numbers for affected units.
Lack of 510(k) clearance.
Adept Medical is recalling T-Tube 12mm silicone ventilation tubes because they lack FDA clearance. This means the product may not be safe for medical use without proper regulatory approval.
The tubes lack FDA clearance, meaning they haven't been approved for safety and effectiveness by the U.S. Food and Drug Administration. This could lead to potential medical risks if used without proper regulatory oversight.
Patients using these tubes for ear ventilation and healthcare providers who purchased them are affected. Those with medical devices requiring regulatory approval are at higher risk.
Check for product code NZ3312-2 and serial numbers from lots 2014-3634, 2016-4779, 2016-4835, 2016-5062, or 2020-9564. The device is sold under the brand Adept Medical.
Review the product code and serial numbers to confirm if your device is affected.
The product lacks FDA 510(k) clearance, meaning it has not been approved for safety and effectiveness.
The recall record does not specify a remedy, so check the product details to see if it is affected.
Look for product code NZ3312-2 and serial numbers from the listed lots: 2014-3634, 2016-4779, 2016-4835, 2016-5062, or 2020-9564.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0968-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0968-2025 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.
