Adept Medical recalls T-Tube 9mm silicone ear tubes due to lack of 510(k) clearance. This affects specific product codes and lots from 2008-2023. Consumers should contact the manufacturer for details.
Lack of 510(k) clearance.
Adept Medical is recalling T-Tube 9mm silicone ear tubes because they lack 510(k) clearance. This means the product may not be safe for medical use as it hasn't been approved by the FDA.
The product lacks 510(k) clearance, which means it has not been approved by the FDA for medical use. This could lead to unsafe medical procedures if used without proper regulatory approval.
People who own or use the T-Tube 9mm silicone ear tubes with the listed product codes and lots from 2008 to 2023 are affected. Medical professionals using these tubes for ear ventilation are at higher risk.
Check the product code (NZ3309) and lot numbers listed in the recall notice, which range from 2008-1459 to 2023-11053. The tubes are made of silicone and are used for ear ventilation.
Identify the product code (NZ3309) and lot numbers from the list provided in the recall notice.
The product lacks 510(k) clearance, meaning it has not been approved by the FDA for medical use.
The recall notice does not specify a remedy, so contact Adept Medical for further instructions.
Yes, the affected lots range from 2008-1459 to 2023-11053.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0966-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0966-2025 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.
