CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Otological Ventilation Tube - T-Tube - Double - Silicone recalled
Adept Medical is recalling Otological Ventilation Tube - T-Tube - Double - Silicone, distributed nationwide in the US. The recall was initiated on 24 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0964-2025
- FDA event ID
- 95942
- Recalling firm
- Adept Medical, Auckland
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Nov 2024
- FDA classified
- 17 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Nov 2024 | Recall initiated by company | |
| 17 Jan 2025 | Classified by FDA | +54 days |
| 29 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of 510(k) clearance.
Product as listed by the FDA
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Where it was distributed
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.
Questions about this recall
Is Otological Ventilation Tube - T-Tube - Double - Silicone recalled?
Yes. Adept Medical recalled Otological Ventilation Tube - T-Tube - Double - Silicone on 24 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0964-2025.
Why was it recalled?
Lack of 510(k) clearance.
Which lots are affected?
Product Code: NZ3306-2; UDI-DI: 09421901970352; Lots: 2009-1820, 2013-3195, 2014-3504, 2015-4220, 2016-4652, 2016-5211, 2019-6966, 2022-10349,
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Adept Medical
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Otological Ventilation Tube - Donaldson - Double - Blue Silicone recalled | Adept Medical | Other | Nationwide |
| Device | CLASS II | Otological Ventilation Tube - T-Tube - Double - Silicone recalled | Adept Medical | Other | Nationwide |
| Device | CLASS II | Otological Ventilation Tube - T-Tube - Silicone recalled | Adept Medical | Other | Nationwide |
| Device | CLASS II | Otological Ventilation Tube - T-Tube - Silicone recalled | Adept Medical | Other | Nationwide |
| Device | CLASS II | Otological Ventilation Tube - T-Tube - Double - Silicone recalled | Adept Medical | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |