FDA Medical Device Recalls (openFDA)
Adept Medical Ltd: Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Recall number
- Z-0965-2025
- Recalling firm
- Adept Medical Ltd
- Product
- Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Status
- Open, Classified
- Initiated
- 2024-11-24
- Posted
- 2025-01-17
- Terminated
- not on file
- Reason
- Lack of 510(k) clearance.
- Root cause
- Device Design
- Action
- 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, yhuang@adept.co.nz and Viv So, Technical File Manager vso@adept.co.nz 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.
- Quantity
- 2,610 units (240 US, 2370 OUS)
- 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.
- Lot, serial or model codes
- Product Code: NZ3309-2; UDI-DI: 09421901970376; Lots: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.
- 510(k) numbers
- ["K061058"]
- PMA numbers
- not on file
- Product code
- ETD
- Firm FEI
- 3006098219
- Firm city
- Auckland
- Firm state
- Morningside
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28