Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and 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: The FDA classified this as a Class II recall. No injuries or illnesses have been reported, and the source text describes only a regulatory non-compliance issue—distribution without required premarket clearance—rather than a specific device defect or known safety hazard.
Plain-English summary
Adept Medical Ltd is recalling 2,610 Otological Ventilation Tube T-Tube 9mm double silicone units (Product Code NZ3309-2, UDI-DI: 09421901970376). The recall was issued because these devices were distributed without required FDA premarket 510(k) clearance.
The affected devices were distributed nationwide in the United States and 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. A total of 240 units were distributed in the US.
The specific lot numbers affected are: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, and 2020-9591.
Consumers and healthcare providers who have received these devices should consult with the manufacturer or their healthcare provider regarding appropriate next steps.
The recalled product
- Product
- Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Manufacturer
- Adept Medical Ltd
- Category
- Medical Device — Otological
- Hazard
- lack-of-authorization
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 (17)
- Product Code: NZ3309-2
- UDI-DI: 09421901970376
- Lots: 2009-1822
- 2012-2723
- 2013-3079
- 2014-3452
- 2014-3506
- 2015-4277
- 2016-4527
- 2016-4664
- 2016-4997
- 2017-5441
- 2017-5674
- 2017-6117
- 2018-6458
- 2018-6896
- 2020-9591.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27