Adept Medical recalls T-Tube 6mm ventilation tubes due to missing FDA clearance. This affects specific product codes and lots. Consumers should contact the company for details.
Lack of 510(k) clearance.
Adept Medical is recalling certain T-Tube 6mm 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. regulatory body. This could lead to medical risks if used without proper oversight.
Patients using these tubes for ear ventilation may be affected. Healthcare providers who use the product are at risk if they have the recalled items.
Check for product code NZ3306-2 and lots numbers like 2009-1820, 2013-3195, or later. The tubes are sold under the brand Adept Medical.
Reach out to Adept Medical for specific instructions on how to handle the recalled product.
The product lacks FDA clearance, meaning it hasn't been approved for safety and effectiveness by the U.S. regulatory body.
Contact Adept Medical directly for specific instructions on handling the recalled product.
The recall is due to missing regulatory approval, which could pose medical risks if used without proper oversight.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0964-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0964-2025 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.
