Class II — Adept Medical Ltd
| Recalling firm | ADEPT MEDICAL LTD |
|---|---|
| Registered facility | ADEPT MEDICAL LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Lack of 510(k) clearance. |
| Product | Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2; |
| Quantity | 310 units (160 US, 150 OUS) |
| Distribution | 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. |
| Initiated | 2024-11-24 |
| Classified | 2025-01-17 |
| Recall number | Z-0968-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Adept Medical Ltd (Z-0968-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95942/
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