Otological Ventilation Tubes Distributed Without FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 device recall based on regulatory non-compliance with no reported illnesses or injuries. The recall is a compliance matter rather than a documented safety defect.
Plain-English summary
Adept Medical Ltd is recalling 2,010 units of otological ventilation tubes (T-Tube 6mm Double Silicone, Product Code: NZ3306-2) distributed without FDA 510(k) clearance. The product is a Class II medical device that requires FDA clearance prior to US distribution.
The recall includes 630 units distributed within the United States and 1,380 units distributed internationally. International distribution includes Canada, New Zealand, Australia, Yemen, the United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, the United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Chile, and Ireland.
Affected lot numbers are 2009-1820, 2013-3195, 2014-3504, 2015-4220, 2016-4652, 2016-5211, 2019-6966, and 2022-10349. Patients, healthcare providers, or others in possession of this product should contact Adept Medical Ltd for instructions regarding the recalled device.
The recalled product
- Product
- Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
- Manufacturer
- Adept Medical Ltd
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 (10)
- Product Code: NZ3306-2
- UDI-DI: 09421901970352
- Lots: 2009-1820
- 2013-3195
- 2014-3504
- 2015-4220
- 2016-4652
- 2016-5211
- 2019-6966
- 2022-10349
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Adept Medical Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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