Otological Ventilation Tube - T-Tube 12mm - Double -… recallZ-0968-2025 · Adept Medical Ltd · initiated Nov 24, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Adept Medical Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lack of 510(k) clearance.
FDA root cause category: Device Design
What the company is doing
On November 25, 2024 distributors were emailed URGENT MEDICAL ADVISORY RECALL NOTICES. We request that you please: 1. Complete the enclosed Recall Acknowledgement Form (even if you have no stock, please confirm via the No Stock tick box). 2. If you have stock, quarantine all stock of the above products. 3. Return the quarantined product to Adept Medical Ltd for credit processing as below. You should also check any stock held elsewhere in your organization. " If returning stock, please return stock with the completed Recall Acknowledgement Form to accompany the returned boxes. " Use our UPS account details as UPS :9F496F , postcode 2022 to process return freight " Send Completed Recall Acknowledgement Form to Yi Huang, Quality and Regulatory Manager, [email protected] and Viv So, Technical File Manager [email protected] We sincerely apologize for the inconvenience caused and assure you that the crediting of your returns will be treated as a matter of utmost urgency.
Recall details
- Recall number
- Z-0968-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 24, 2024
- Posted by the FDA
- Jan 17, 2025
- Recalling firm
- Adept Medical Ltd
- Quantity
- 310 units (160 US, 150 OUS)
- Product code
- ETD
- FDA submissions
- K061058
- 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.
Product description
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Code information (models, lots, serial numbers)
Product Code: NZ3312-2; UDI-DI: 09421901970390; Lots: 2014-3634, 2016-4779, 2016-4835, 2016-5062, 2020-9564.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NeoZoline NZ3312-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
Other devices under the same FDA submission
7 devices cleared under K061058 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NeoZoline NZ3306Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3306-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3309Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3309-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3312Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3321Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3321-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95942).
- Z-0963-2025 · Open, ClassifiedOtological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
- Z-0964-2025 · Open, ClassifiedOtological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
- Z-0965-2025 · Open, ClassifiedOtological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Z-0966-2025 · Open, ClassifiedOtological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
- Z-0967-2025 · Open, ClassifiedOtological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
- Z-0969-2025 · Open, ClassifiedOtological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
- Z-0970-2025 · Open, ClassifiedOtological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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