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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95605

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

Open FDA event record

Event summary

Timeline bucket
October 28, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD, Inc.

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

3 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 3

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Z-0527-2025
Recall number
Z-0527-2025
Initiated
October 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
142327 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Code information

REF 14-504-17, UDI/DI 35021239002579, Lot Numbers: 0003340, 0003620, 0003616, 0003580, 0003542, 0003509, 0003579, 0003568, 0003599, 0003615, 0003589, 0003562, 0003601, 0003618, 0003583, 0003613, 0003270, 0003629, 0003293, 0003584, 0003487, 0003617, 0003280, 0003348, 0003470, 0003523, 0003607, 0003576, 0003422, 0003614, 0003633, 0003578, 0003630, 0003207, 0003438, 0003559, 0003570, 0003478, 0003533, 0003588, 0003433, 0003556, 0003561, 0003446, 0003284, 0003545, 0003461, 0003590, 0003398, 0003530, 0003539, 0003550, 0003213, 0003598, 0003623, 0003504, 0003548, 0003552, 0003631, 0003594, 0003625, 0003600, 0003378, 0003526, 0003574, 0003411, 0003471, 0003587, 0003596, 0003297, 0003298, 0003412, 0003424, 0003425, 0003517, 0003151, 0003163, 0003235, 0003347, 0003350, 0003382, 0003390, 0003416, 0003423, 0003603, 0003638, 0003641, 0003175, 0003214, 0003238, 0003253, 0003257, 0003343, 0003351, 0003388, 0003397, 0003428, 0003486, 0003488, 0003496, 0003498, 0003528, 0003541, 0003608, 0003610, 0003612, 0003639, 0003640, 0003121, 0003122, 0003123, 0003125, 0003126, 0003127, 0003128, 0003129, 0003131, 0003132, 0003133, 0003134, 0003135, 0003136, 0003137, 0003138, 0003141, 0003142, 0003143, 0003145, 0003146, 0003147, 0003149, 0003150, 0003153, 0003154, 0003155, 0003156, 0003157, 0003158, 0003159, 0003160, 0003164, 0003166, 0003167, 0003168, 0003170, 0003171, 0003172, 0003173, 0003174, 0003176, 0003177, 0003178, 0003179, 0003180, 0003181, 0003182, 0003183, 0003188, 0003190, 0003191, 0003192, 0003193, 0003194, 0003195, 0003197, 0003198, 0003199, 0003200, 0003201, 0003202, 0003203, 0003208, 0003209, 0003211, 0003212, 0003215, 0003217, 0003219, 0003220, 0003221, 0003223, 0003224, 0003225, 0003227, 0003228, 0003229, 0003230, 0003231, 0003233, 0003234, 0003237, 0003239, 0003240, 0003241, 0003242, 0003243, 0003244, 0003245, 0003246, 0003247, 0003248, 0003249, 0003250, 0003251, 0003252, 0003258, 0003259, 0003260, 0003261, 0003262, 0003263, 0003264, 0003265, 0003266, 0003268, 0003269, 0003271, 0003272, 0003273, 0003274, 0003275, 0003278, 0003279, 0003281, 0003282, 0003283, 0003285, 0003286, 0003287, 0003288, 0003289, 0003290, 0003291, 0003292, 0003294, 0003295, 0003296, 0003299, 0003302, 0003303, 0003304, 0003305, 0003306, 0003309, 0003310, 0003311, 0003312, 0003313, 0003316, 0003317, 0003318, 0003319, 0003320, 0003321, 0003323, 0003324, 0003325, 0003326, 0003327, 0003328, 0003330, 0003331, 0003332, 0003333, 0003334, 0003335, 0003336, 0003337, 0003338, 0003341, 0003342, 0003344, 0003345, 0003346, 0003349, 0003352, 0003353, 0003354, 0003355, 0003356, 0003365, 0003366, 0003379, 0003383, 0003384, 0003385, 0003386, 0003387, 0003389, 0003392, 0003396, 0003400, 0003401, 0003402, 0003404, 0003405, 0003406, 0003407, 0003408, 0003409, 0003410, 0003413, 0003417, 0003418, 0003419, 0003420, 0003421, 0003426, 0003427, 0003429, 0003430, 0003431, 0003432, 0003434, 0003435, 0003436, 0003437, 0003439, 0003440, 0003441, 0003442, 0003443, 0003444, 0003445, 0003447, 0003448, 0003450, 0003451, 0003452, 0003453, 0003454, 0003455, 0003458, 0003460, 0003462, 0003463, 0003464, 0003465, 0003466, 0003467, 0003468, 0003472, 0003473, 0003474, 0003475, 0003479, 0003481, 0003482, 0003485, 0003490, 0003491, 0003493, 0003494, 0003495, 0003497, 0003499, 0003501, 0003502, 0003503, 0003505, 0003506, 0003507, 0003508, 0003512, 0003513, 0003514, 0003515, 0003516, 0003518, 0003519, 0003520, 0003521, 0003524, 0003525, 0003527, 0003531, 0003532, 0003534, 0003535, 0003536, 0003537, 0003538, 0003543, 0003544, 0003547, 0003551, 0003554, 0003560, 0003565, 0003566, 0003582, 0003586, 0003591, 0003592, 0003593, 0003595, 0003602, 0003604, 0003606, 0003611, 0003624, 0003632, 0003636, 0003637, 0003642, 0003575, 0003540, 0003572, 0003558, 0003555, 0003567, 0003585, 0003546, 0003609, 0003564, 0003563, 0003571, 0003577, 0003569; REF 14-504-17JP, UDI/DI 35021239002579, Lot Numbers: 0003215, 0003415, 0003483

Distribution pattern

Worldwide distribution.

device · product 2 of 3

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

Z-0528-2025
Recall number
Z-0528-2025
Initiated
October 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
10,223 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Code information

REF 14-504-68, UDI/DI 35021239002586, Lot Numbers: 0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643; REF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers: 0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643

Distribution pattern

Worldwide distribution.

device · product 3 of 3

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

Z-0529-2025
Recall number
Z-0529-2025
Initiated
October 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
12282 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Code information

UDI/DI 35021239002593, Lot Numbers: 0003373, 0003456, 0003621, 0003374, 0003376, 0003375, 0003459, 0003391, 0003480, 0003549, 0003301, 0003124, 0003130, 0003139, 0003140, 0003144, 0003148, 0003152, 0003161, 0003169, 0003185, 0003205, 0003210, 0003222, 0003232, 0003236, 0003255, 0003276, 0003277, 0003315, 0003329, 0003339, 0003367, 0003370, 0003371, 0003372, 0003381, 0003395, 0003399, 0003403, 0003414, 0003449, 0003457, 0003469, 0003476, 0003477, 0003489, 0003492, 0003500, 0003573, 0003484, 0003619, 0003557, 0003510, 0003522, 0003597, 0003511, 0003622, 0003553, 0003581, 0003605, 0003529,

Distribution pattern

Worldwide distribution.