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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68739

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

Open FDA event record

Event summary

Timeline bucket
July 07, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
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

6 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 6

4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

Z-2536-2014
Recall number
Z-2536-2014
Initiated
July 07, 2014
Classification
Class I
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Code information

Lot Numbers: 2470635, 2453453, 2443370, 2438608, 2412131, 2394050, 2380339, 2380338, 2376475, 2361590, 2352067, 2322810, 2271334, 2260548, 2223901, 2208177, 2202236, 2191909, 2161059, 2077168, 2042400, 12050

Distribution pattern

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.

device · product 2 of 6

H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

Z-2537-2014
Recall number
Z-2537-2014
Initiated
July 07, 2014
Classification
Class I
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Code information

Lot Numbers: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733, 2405732, 2394049, 2394048, 2394047, 2389237, 2389236, 2385647, 2380340, 2376638, 2376473, 2371941, 2365534, 2361589, 2357817, 2357816, 2353342, 2347040, 2343290, 2339700, 2335460, 2326892, 2322812, 2309462, 2298736, 2298735, 2286584, 2278061, 2263550, 2260549, 2250041, 2233738, 2228354, 2219206, 2211922, 2208179, 2191911, 2188447, 2179221, 2175047, 2154527, 2152029, 2142174, 2128628, 2119944, 2109010, 2099495, 2090213, 2068117, 2063968, 2063967, 2042403, 12049, 12047, 12044, 11669, 11403

Distribution pattern

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.

device · product 3 of 6

H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

Z-2538-2014
Recall number
Z-2538-2014
Initiated
July 07, 2014
Classification
Class I
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Code information

Lot Numbers: 2474641, 2470638, 2453454, 2448650, 2438611, 2433436, 2428205, 2412133, 2400804, 2347041, 2343292, 2326893, 2298737, 2271338, 2260550, 2211923, 2188448, 2175049, 2135974, 2099500, 2068120, 2042404, 11872, 11861

Distribution pattern

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.

device · product 4 of 6

H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit

Z-2539-2014
Recall number
Z-2539-2014
Initiated
July 07, 2014
Classification
Class I
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Code information

Lot Numbers: 2481849, 2474643, 2470640, 2470639, 2465819, 2462292, 2462291, 2457748, 2453455, 2448671, 2443372, 2438612, 2428206, 2420088, 2412135, 2394046, 2394045, 2394044, 2385648, 2380341, 2376618, 2376489, 2365439, 2361588, 2343298, 2329576, 2326894, 2322814, 2317088, 2309465, 2309464, 2298739, 2298738, 2286586, 2278062, 2271339, 2188449, 2179222, 2164289, 2146292, 2142175, 2137959, 2128629, 2119945, 2109011, 2099501, 2090215, 2068121, 2063971, 2063970, 2042408, 12046, 11871, 11862, 11858, 11696, 11693, 11656, 11653

Distribution pattern

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.

device · product 5 of 6

H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit

Z-2540-2014
Recall number
Z-2540-2014
Initiated
July 07, 2014
Classification
Class I
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Code information

Lot Numbers: 2597332, 2585074, 2580798, 2576365, 2564404, 2564403, 2563088, 2549367, 2519413, 2500170, 2488207, 2474646, 2465828, 2453473, 2443378, 2438615, 2433450, 2412145, 2380351, 2376498, 2365494, 2365493, 2361580, 2357823, 2353347, 2343313, 2329583, 2326899, 2322825, 2298752, 2286594, 2278069, 2271358, 2263553, 2260562, 2260561, 2250053, 2250052, 2250050, 2250049, 2244749, 2228363, 2219213, 2211929, 2208194, 2191930, 2179229, 2175056, 2154534, 2142178, 2135983, 2128635, 2124241, 2120119, 2116099, 2090223, 2077179, 2063989, 2063988, 12040, 12033, 11877, 11876, 11874, 11873, 11679, 11655, 11407, 11405

Distribution pattern

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.

device · product 6 of 6

H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit

Z-2541-2014
Recall number
Z-2541-2014
Initiated
July 07, 2014
Classification
Class I
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
135,518 (110,246 nationwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Code information

Lot Numbers: 2602399, 2588625, 2580799, 2576366, 2523679, 2513119, 2492246, 2481855, 2474647, 2465829, 2457754, 2443379, 2438616, 2433451, 2428215, 2412146, 2394061, 2380352, 2376566, 2365454, 2361579, 2357822, 2347642, 2343312, 2343311, 2329584, 2322827, 2309473, 2298755, 2298754, 2286596, 2271359, 2250054, 2244752, 2244751, 2228364, 2211930, 2208196, 2191931, 2188460, 2179231, 2175057, 2154535, 2152054, 2146301, 2142179, 2135984, 2128636, 2120121, 2116100, 2109019, 2090224, 2077180, 2068123, 2063991, 2063990, 11889, 11870, 11859, 11697, 11695, 11694, 11657, 11654, 11406

Distribution pattern

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.