Adept Medical recalls Otological Ventilation Tubes with specific product codes due to lack of FDA 510(k) clearance. Consumers should check their product codes and contact the company for details.
Lack of 510(k) clearance.
Adept Medical is recalling certain Otological Ventilation Tubes because they lack FDA 510(k) clearance. This means the product may not be safe for medical use without proper regulatory approval.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure safety and effectiveness. Without this clearance, the tubes may not meet the necessary standards for medical use, potentially leading to health risks.
Patients using the recalled Otological Ventilation Tubes for ear conditions are affected. Healthcare providers who have these tubes in their inventory may also be impacted.
Check the product code on the tube, which includes specific lots like 2015-4222 through 2023-11068. The product is sold under the brand name Donaldson Double Blue Silicone.
Look for the product code on the tube, which includes specific lots such as 2015-4222 through 2023-11068.
The product lacks FDA 510(k) clearance, which is required for medical devices to ensure safety and effectiveness.
Check the product code on the tube, which includes specific lots such as 2015-4222 through 2023-11068.
The recall record does not specify a remedy, so contact Adept Medical for further instructions.
We’ve drafted a message you can send Adept Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0970-2025 — Adept Medical Adept Medical Hello, I own a Adept Medical that is covered by recall Z-0970-2025 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.
