Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0967-2025·Announced 2025-01-29

Otological Ventilation Tube Recalled Due to Lack of Regulatory Clearance

Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects approximately 2,190 units in the US.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is lack of required 510(k) clearance prior to distribution, which is a regulatory compliance issue rather than a reported safety incident.

Plain-English summary

Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 12mm, silicone, Product Code NZ3312) due to lack of FDA 510(k) regulatory clearance prior to distribution.

The affected product (UDI-DI: 09421901970383) includes approximately 5,120 units, with 2,190 units distributed in the United States and 2,930 units distributed 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. Multiple lot numbers are affected, including lots 2008-1461 through 2023-10966.

The recall is classified as FDA Class II and does not involve any reported illnesses or injuries. Consumers who possess this product should contact Adept Medical Ltd or their healthcare provider with questions about this recall.

The recalled product

Product: Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Manufacturer: Adept Medical Ltd
Category: Medical Device — Otological / ENT
Hazard: regulatory-clearance-violation

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 (19)

Product Code: NZ3312
UDI-DI: 09421901970383
Lots: 2008-1461
2011-2537
2012-2689
2012-2842
2015-3945
2015-4400
2016-4554
2016-4662
2016-5199
2016-5283
2017-6007
2019-6984
2020-9242
2020-9690
2021-10187
2021-9918
2023-10966

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 for Lack of FDA Premarket Clearance
FDA (Devices) · 2025-01-29
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
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 · regulatory clearance violation