Adept Medical Ltd recalls Donaldson Blue Silicone Otological Ventilation Tubes with Product Code NZ3321 due to lack of 510(k) clearance. Affected units include specific production lots from 2015-2023.
Lack of 510(k) clearance.
Adept Medical Ltd is recalling Donaldson Blue Silicone Otological Ventilation Tubes with Product Code NZ3321 because they lack 510(k) clearance. This means the product may not meet safety standards for medical use, potentially posing risks to patients.
The product lacks 510(k) clearance, which is a regulatory requirement for medical devices in the U.S. This means the device may not have been tested for safety and effectiveness before being marketed, potentially leading to health risks if used improperly.
Patients using the Donaldson Blue Silicone Otological Ventilation Tubes for medical purposes are affected. Healthcare providers and patients who have the specific product lots listed in the recall are most at risk.
Check for the product code NZ3321 on the device. Affected units include specific production lots from 2015-2023 as listed in the recall notice.
Look for the product code NZ3321 and specific production lots listed in the recall (2015-2023).
The product lacks 510(k) clearance, which is a regulatory requirement for medical devices in the U.S. This means the device may not have been tested for safety and effectiveness before being marketed.
The recall record does not specify a remedy, so there is no action required beyond checking if your product is affected.
Affected lots include 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, and 2023-11130.
We’ve drafted a message you can send Donaldson to request your refund or repair — edit it as you like.
Subject: Recall Z-0969-2025 — Donaldson Donaldson Hello, I own a Donaldson that is covered by recall Z-0969-2025 from Donaldson. 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.
