Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.
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 recall with no reported illnesses or injuries. The hazard is regulatory non-compliance (lack of 510(k) pre-market approval) rather than a specific product defect or contamination. Per the rubric, recalls with no reported harm and theoretical hazards score at most 3, and this precautionary regulatory recall appropriately scores as moderate.
Plain-English summary
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes, T-Tube 12mm, Double, Silicone (Product Code NZ3312-2) due to lack of FDA 510(k) clearance. Affected lot numbers are 2014-3634, 2016-4779, 2016-4835, 2016-5062, and 2020-9564.
The recalled devices were distributed without obtaining FDA 510(k) pre-market approval, which is required for marketing medical devices in the United States.
Domestically, 160 units were distributed throughout the US. Internationally, 150 units were distributed to Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, and Chile.
Healthcare providers and patients who have received or are using these devices should discontinue use and contact the manufacturer, Adept Medical Ltd, for further instructions.
The recalled product
- Product
- Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
- Manufacturer
- Adept Medical Ltd
- Hazard
- regulatory-non-compliance
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 (7)
- Product Code: NZ3312-2
- UDI-DI: 09421901970390
- Lots: 2014-3634
- 2016-4779
- 2016-4835
- 2016-5062
- 2020-9564.
Distribution
Distributed nationwide across the United States.
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