Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Adept Medical Ltd
- Reason for Recall:
- Lack of 510(k) clearance.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Product Codes/Lot Numbers:
Product Code: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0969-2025
Related Recalls
Class I - Dangerous
Lack of 510(k) clearance.
Class I - Dangerous
Lack of 510(k) clearance.
Class I - Dangerous
Lack of 510(k) clearance.