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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67266

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

Open FDA event record

Event summary

Timeline bucket
January 06, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

14 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 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0950-2014
Recall number
Z-0950-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 2 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0951-2014
Recall number
Z-0951-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13013, Lot numbers: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298, 01F1100648, 01H1100367, 01L1100147, 01J1100232, 01L1100371, 01M1100176, 01C1200083, 01E1200461, 01E1200545, 01H1200156, 01F1200171, 01A1300637, 01F1300055 and 01F1300297.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 3 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0952-2014
Recall number
Z-0952-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13014, Lot numbers: 01A1000326, 01B1000081, 01A1000502, 01B1000256, 01A1000549, 01G1000048, 01J1000341, 01M1000185, 01C1100227, 01C1100150, 01B1100464, 01B1100237, 01E1100346, 01F1100505, 01D1100077, 01F1100031, 01H1100158, 01D1100330, 01C1100371, 01C1100400, 01C1100626, 01C1200266, 01D1200419, 01C1200466, 01E1200204, 01D1100299, 01F1200172, 01H1200411, 01K1200231, 01G1200206, 01J1200072, 01G1200285, 01G1200452, 01E1200546, 01L1200131, 01K1200336 and 01E1300296.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 4 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0953-2014
Recall number
Z-0953-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095 and 01H1300325, 01J1300002.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 5 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0954-2014
Recall number
Z-0954-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13016, Lot numbers: 01A1000317, 01C1000059, 01D1000386, 01D1000112, 01G1000245, 01J1000396, 01M1000284, 01B1100011, 01B1100070, 01C1100114, 01C1100529, 01E1100227, 01C1100606, 01B1100505, 01B1100248, 01H1100103, 01A1200116, 01B1200547, 01B1200422, 01E1100492, 01C1200085, 01C1200385, 01D1100348, 01D1200270, 01D1200087, 01G1100117, 01E1200562, 01G1200079, 01C1300339, 01C1300437, 01D1300076, 01E1300297, 01D1300194 and 01E1300061.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 6 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0955-2014
Recall number
Z-0955-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13017, Lot numbers: 01L1000137, 01L1000160, 01A1100210, 01B1100506, 01D1100318, 01E1100525, 01E1100348, 01G1100439, 01G1100118, 01B1100199, 01L1100332, 01J1100026, 01C1200267, 01K1100240, 01D1200088, 01H1200524, 01G1200207, 01J1200353, 01D1300077, 01E1300117, 01K1300108 and 01K1300479.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 7 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0956-2014
Recall number
Z-0956-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-13018, Lot numbers: 01A1000435, 01D1000122, 01G1000099, 01J1000398, 01A1100276, 01A1100516, 01B1100012, 01F1100336, 01C1100113, 01A1200212, 01G1200208, 01G1100440 and 01D1100342

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 8 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0957-2014
Recall number
Z-0957-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14012, Lot numbers: 01A1200213 and 01A1200341.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 9 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0958-2014
Recall number
Z-0958-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14013, Lot numbers: 01A1200341 and 01B1200423.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 10 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0959-2014
Recall number
Z-0959-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14014, Lot numbers: 01B1200106, 01D1200157 and 01B1200424.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 11 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0960-2014
Recall number
Z-0960-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14015, Lot numbers: 01B1200107, 01J1200211, 01C1200387, 01H1200157, 01E1300478 and 01K1300343.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 12 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0961-2014
Recall number
Z-0961-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14016, Lot numbers: 01B1200214, 01E1200462, 01B1200335, 01C1200468, 01J1300036 and 01J1300339.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 13 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0962-2014
Recall number
Z-0962-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14017, Lot numbers: 01B1200215.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

device · product 14 of 14

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Z-0963-2014
Recall number
Z-0963-2014
Initiated
January 06, 2014
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,871 each (148, 275 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tracheal tube can kink during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tracheal tube can kink during patient use.

Code information

Product Code: 5-14018, Lot numbers: 01B1200213 and 01B1200336.

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.