Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Otological Ventilation Tube - Donaldson - Blue Silicone Recalled by Adept Medical Ltd Due to Lack of 510(k) clearance.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Adept Medical Ltd directly.
Affected Products
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Quantity: 2,440 units (1940 US, 500 OUS)
Why Was This Recalled?
Lack of 510(k) clearance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Adept Medical Ltd
Adept Medical Ltd has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report