Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product—a medical device distributed without FDA 510(k) premarket clearance establishing safety and efficacy—and no injuries have been reported, placing it at severity level 3 per the rubric.
Plain-English summary
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone), Product Code NZ3309. Approximately 6,280 units were affected, with 2,500 distributed in the United States and 3,780 distributed internationally.
The recall was issued because these devices were distributed without FDA 510(k) premarket notification clearance. Under FDA regulations, medical devices must obtain this clearance before being legally marketed in the United States.
The affected units were distributed nationwide throughout 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.
The recalled product
- Product
- Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
- Manufacturer
- Adept Medical Ltd
- Hazard
- regulatory-non-compliance
- 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 (20)
- Product Code: NZ3309
- UDI-DI: 09421901970369
- Lots: 2008-1459
- 2009-1864
- 2011-2331
- 2012-2961
- 2013-3122
- 2013-3363
- 2014-3783
- 2014-3832
- 2015-3943
- 2016-4601
- 2016-5197
- 2017-5651
- 2017-6150
- 2018-6487
- 2018-6818
- 2019-7211
- 2021-10033
- 2022-10783
Distribution
Distributed nationwide across the United States.
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