Recall archive / FDA device enforcement
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2; — FDA record Z-0968-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 24, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
- Reason
- Lack of 510(k) clearance.
- Classification
- Class II
- Recalling firm
- Adept Medical Ltd
- Quantity
- 310 units (160 US, 150 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0968-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Code: NZ3312-2; UDI-DI: 09421901970390; Lots: 2014-3634, 2016-4779, 2016-4835, 2016-5062, 2020-9564. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 29, 2025
- Recall initiation date
- Nov 24, 2024
- Center classification date
- Jan 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.