Otological Ventilation Tube Recalled Due to Lack of FDA Clearance
Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects 4,080 units distributed in the US and internationally.
What this means for you
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: This is an FDA Class II recall for lack of 510(k) clearance. No illnesses or injuries have been reported. The recall is regulatory in nature, reflecting failure to obtain required FDA approval before distribution.
Plain-English summary
Adept Medical Ltd is recalling Otological Ventilation Tubes (Donaldson, Double, Blue Silicone; Product Code NZ3321-2). The recall is due to lack of FDA 510(k) clearance. A total of 4,080 units were affected, with 1,510 distributed in the United States and 2,570 distributed internationally.
The product was distributed nationwide in the United States and to customers in 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. Affected lot numbers include: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, and 2023-11068. The FDA and manufacturer continue to review this matter.
The recalled product
- Product
- Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
- Manufacturer
- Adept Medical Ltd
- Hazard
- improper-approval
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 (15)
- Product Code: NZ3321-2
- UDI-DI: 09421901970413
- Lots: 2015-4222
- 2016-4893
- 2016-5236
- 2016-5408
- 2017-5538
- 2017-5790
- 2017-6047
- 2017-6233
- 2018-6361
- 2018-6735
- 2019-6970
- 2022-10451
- 2023-11068.
Distribution
Distributed nationwide across the United States.
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