Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0965-2025·Announced 2025-01-29

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.

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: 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.

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 →

Same manufacturer · Adept Medical Ltd

See all →

Moderate
Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance
FDA (Devices) · 2025-01-29
Moderate
Otological Ventilation Tube Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2025-01-29
Moderate
Otological Ventilation Tube Recalled Due to Lack of Regulatory Clearance
FDA (Devices) · 2025-01-29
High
Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance
FDA (Devices) · 2025-01-29
High
Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
FDA (Devices) · 2025-01-29

Same hazard · lack of authorization