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Adept Medical Ltd FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;Class IINov 24, 2024Lack of 510(k) clearance. |
| Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;Class IINov 24, 2024Lack of 510(k) clearance. |