Otological Ventilation Tubes Recalled for Lack of FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall due to regulatory non-compliance (lack of 510(k) clearance) rather than an identified product defect. No reported illnesses, injuries, or adverse events have been documented.
Plain-English summary
Adept Medical Ltd is recalling 2,440 Otological Ventilation Tubes (Product Code NZ3321, Blue Silicone, Donaldson model) due to lack of FDA 510(k) clearance. Approximately 1,940 units were distributed in the United States, and 500 units were distributed internationally to countries including Canada, New Zealand, Australia, United Kingdom, Spain, Italy, Turkey, Germany, Greece, and others.
The devices were marketed without the FDA 510(k) regulatory review and clearance required before commercial distribution of medical devices. No reported illnesses, injuries, or adverse events have been documented in connection with this product.
Affected lot numbers include 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, and 2023-11130. The device UDI-DI is 09421901970406. Patients and healthcare providers with these devices should contact Adept Medical Ltd for further guidance.
The recalled product
- Product
- Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
- Manufacturer
- Adept Medical Ltd
- Category
- Medical Device — Otological
- Hazard
- uncleared-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Product Code: NZ3321
- UDI-DI: 09421901970406
- Lots: 2017-5547
- 2018-6609
- 2023-10988
- 2015-4105
- 2016-4595
- 2016-4760
- 2016-5201
- 2017-5536
- 2017-5547
- 2019-7331
- 2023-11130.
Distribution
Distributed nationwide across the United States.
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