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.
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 3/5 (High).
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
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.
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
Same manufacturer · Adept Medical Ltd
See all →- ModerateOtological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
FDA (Devices) · 2025-01-29
- ModerateOtological Ventilation Tubes recalled due to lack of FDA 510(k) clearance
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