Adept Medical recalls T-Tube 6mm silicone ear tubes due to lack of 510(k) clearance. Affected units include specific product codes and production lots from 2008-2023. Consumers should check their product details.
Lack of 510(k) clearance.
Adept Medical is recalling T-Tube 6mm silicone ear tubes because they lack 510(k) clearance. This means the product hasn't been approved for safety by the FDA, which could pose risks during medical use.
The product lacks 510(k) clearance, which means it hasn't been approved by the FDA for safety and effectiveness. This could lead to improper medical use if the tubes don't meet required standards.
People who own or use the T-Tube 6mm silicone ear tubes with product codes NZ3306 or NZ3306-2 are affected. Those using the tubes for medical purposes are most at risk.
Check for product codes NZ3306 or NZ3306-2 on the tube packaging. Look for specific production lots listed in the recall notice, such as 2008-1457 through 2023-11542.
Identify your product code and lot number to confirm if it's affected by this recall.
The product lacks 510(k) clearance, meaning it hasn't been approved by the FDA for safety and effectiveness.
Check your product code and lot number to see if it's affected. If it is, contact Adept Medical for further instructions.
The recall indicates the product hasn't been approved for safety, but specific risks aren't detailed in the notice.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0963-2025 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.
