Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

Product Codes/Lot Numbers:

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, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0965-2025

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