Otological Ventilation Tube Recalled Due to Lack of Regulatory Clearance
Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects approximately 2,190 units in the US.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is lack of required 510(k) clearance prior to distribution, which is a regulatory compliance issue rather than a reported safety incident.
Plain-English summary
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 12mm, silicone, Product Code NZ3312) due to lack of FDA 510(k) regulatory clearance prior to distribution.
The affected product (UDI-DI: 09421901970383) includes approximately 5,120 units, with 2,190 units distributed in the United States and 2,930 units distributed internationally to Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Chile, and Ireland. Multiple lot numbers are affected, including lots 2008-1461 through 2023-10966.
The recall is classified as FDA Class II and does not involve any reported illnesses or injuries. Consumers who possess this product should contact Adept Medical Ltd or their healthcare provider with questions about this recall.
The recalled product
- Product
- Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
- Manufacturer
- Adept Medical Ltd
- Hazard
- regulatory-clearance-violation
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 (19)
- Product Code: NZ3312
- UDI-DI: 09421901970383
- Lots: 2008-1461
- 2011-2537
- 2012-2689
- 2012-2842
- 2015-3945
- 2015-4400
- 2016-4554
- 2016-4662
- 2016-5199
- 2016-5283
- 2017-6007
- 2019-6984
- 2020-9242
- 2020-9690
- 2021-10187
- 2021-9918
- 2023-10966
Distribution
Distributed nationwide across the United States.
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