Device recall: Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Class II FDA enforcement event 95942. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Lack of 510(k) clearance.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Adept Medical Ltd started this device recall on 24 Nov 2024. The firm address in the FDA record is in Auckland. FDA put the recall in Class II. FDA event 95942 has 8 product records. The first FDA enforcement report date is 29 Jan 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru,…
Recalling firm
Adept Medical Ltd, Auckland, New Zealand.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0963-2025 | Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2; | 13,070 units (9090 US, 3980 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0964-2025 | Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2; | 2,010 units (630 US, 1380 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0965-2025 | Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2; | 2,610 units (240 US, 2370 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0966-2025 | Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; | 6,280 units (2500 US, 3780 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0967-2025 | Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312; | 5,120 units (2190 US, 2930 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0968-2025 | Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2; | 310 units (160 US, 150 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0969-2025 | Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; | 2,440 units (1940 US, 500 OUS) | Class II | Ongoing | 29 Jan 2025 |
| Z-0970-2025 | Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2; | 4,080 units (1510 US, 2570 OUS) | Class II | Ongoing | 29 Jan 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 8
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0963-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95942. https://recallregister.com/fda/ii/95942/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 95942?
- The event has 8 product records. The first record gives this quantity:
13,070 units (9090 US, 3980 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.