Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 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: Classified as High: an unapproved medical device represents a risk-of-harm product lacking required FDA 510(k) clearance. No illnesses or injuries have been reported in the source material.
Plain-English summary
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes (T-Tube 6mm, Silicone; Product Code NZ3306/NZ3306-2) because the devices were distributed without FDA 510(k) clearance, a required regulatory approval prior to marketing and sale.
The affected devices were distributed nationwide throughout the United States (9,090 units) and internationally to multiple countries (3,980 units). Affected lot numbers range from 2008-1457 through 2023-11542.
The FDA has classified this as a Class II recall. Physicians and patients in possession of these devices should consult their healthcare provider for guidance regarding the safety and appropriate use or discontinuation of the device.
Additional information about this recall is available from the FDA or by contacting Adept Medical Ltd.
The recalled product
- Product
- Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/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 (20)
- Product Code: NZ3306
- UDI-DI: 09421901970345 (NZ3306)
- Lots: 2008-1457
- 2008-1525
- 2009-1845
- 2010-2037
- 2011-2486
- 2013-3120
- 2013-3221
- 2014-3428
- 2014-3519
- 2014-3615
- 2015-4103
- 2016-4599
- 2016-5195
- 2017-5591
- 2017-5812
- 2018-6393
- 2019-7042
- 2019-9076
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
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