NeoZoline NZ3309-2Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K061058); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Nov 24, 2024Open, Classified

   Lack of 510(k) clearance.

   Z-0965-2025 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061058. One submission often covers many models, so check the product and lot details in each record.

• Z-0963-2025 · Nov 24, 2024 · Open, Classified
  Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
• Z-0967-2025 · Nov 24, 2024 · Open, Classified
  Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
• Z-0969-2025 · Nov 24, 2024 · Open, Classified
  Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
• Z-0970-2025 · Nov 24, 2024 · Open, Classified
  Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
• Z-0966-2025 · Nov 24, 2024 · Open, Classified
  Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
• Z-0968-2025 · Nov 24, 2024 · Open, Classified
  Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;