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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95942

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 24, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Adept Medical Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Z-0963-2025
Recall number
Z-0963-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
13,070 units (9090 US, 3980 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3306; UDI-DI: 09421901970345 (NZ3306); Lots: 2008-1457, 2008-1525, 2009-1845, 2010-2037, 2011-2486, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2020-9292, 2020-9476, 2022-10874, 2023-11128, 2023-11542,

Distribution pattern

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.

device · product 2 of 8

Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

Z-0964-2025
Recall number
Z-0964-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
2,010 units (630 US, 1380 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3306-2; UDI-DI: 09421901970352; Lots: 2009-1820, 2013-3195, 2014-3504, 2015-4220, 2016-4652, 2016-5211, 2019-6966, 2022-10349,

Distribution pattern

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.

device · product 3 of 8

Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

Z-0965-2025
Recall number
Z-0965-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
2,610 units (240 US, 2370 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

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.

Distribution pattern

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.

device · product 4 of 8

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Z-0966-2025
Recall number
Z-0966-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
6,280 units (2500 US, 3780 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2014-3783, 2014-3832, 2015-3943, 2016-4601, 2016-5197, 2017-5651, 2017-6150, 2018-6487, 2018-6818, 2019-7211, 2021-10033, 2022-10783, 2023-11053,

Distribution pattern

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.

device · product 5 of 8

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

Z-0967-2025
Recall number
Z-0967-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
5,120 units (2190 US, 2930 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3312; UDI-DI: 09421901970383; Lots: 2008-1461, 2011-2537, 2012-2689, 2012-2842, 2015-3945, 2015-4400, 2016-4554, 2016-4662, 2016-5199, 2016-5283, 2017-6007, 2019-6984, 2020-9242, 2020-9690, 2021-10187, 2021-9918, 2023-10966,

Distribution pattern

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.

device · product 6 of 8

Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

Z-0968-2025
Recall number
Z-0968-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
310 units (160 US, 150 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3312-2; UDI-DI: 09421901970390; Lots: 2014-3634, 2016-4779, 2016-4835, 2016-5062, 2020-9564.

Distribution pattern

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.

device · product 7 of 8

Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

Z-0969-2025
Recall number
Z-0969-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
2,440 units (1940 US, 500 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.

Distribution pattern

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.

device · product 8 of 8

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

Z-0970-2025
Recall number
Z-0970-2025
Initiated
November 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Adept Medical Ltd
Quantity
4,080 units (1510 US, 2570 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510(k) clearance.

Code information

Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068.

Distribution pattern

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.