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Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Recalled January 29, 2025 · FDA recall Z-0965-2025 · Adept Medical
Hazard
Lack of 510(k) clearance. · FDA Class II
Units
2,610 units (240 US, 2370 OUS)
Sold at
US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
Description
Lack of 510(k) clearance.
Product
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Manufacturer(s)
Adept Medical Ltd
Made in
New Zealand
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →