Adept Medical recalls T-Tube 9mm silicone ventilation tubes due to lack of 510(k) clearance. Affected units have specific product codes and lots numbers listed in the recall.
Lack of 510(k) clearance.
Adept Medical is recalling T-Tube 9mm silicone ventilation tubes that lack 510(k) clearance. This means the product may not meet U.S. safety standards, though the recall does not specify immediate risks to users.
The product lacks 510(k) clearance, which is required for medical devices to be safe and effective in the U.S. This means the tubes may not meet federal safety standards, but the recall does not describe specific hazards like injury or malfunction.
Patients using the T-Tube 9mm ventilation tubes for ear conditions are likely affected. Those with the specific product codes and lots numbers listed in the recall are most at risk.
Check for product code NZ3309-2 and lots numbers listed: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.
Identify if your tube has product code NZ3309-2 and one of the listed lots numbers.
The product lacks 510(k) clearance, which is required for medical devices to meet U.S. safety standards.
The recall does not specify a remedy, so check the product details to see if it matches the listed codes and lots numbers.
The recall does not describe specific hazards like injury or malfunction, so the risk level is unknown.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0965-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0965-2025 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.
