Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Affected Product

For affected lots, see full list of affected devices below.

What to Do

• Do not use affected ORAL/NASAL Endotracheal Tubes.

On February 13, 2025, Smiths Medical sent all affected customers an Urgent Medical Device Correction recommending the following actions: 

• Check inventory and stop use of affected products. 
• Destroy all affected products. If destruction is not possible, quarantine until the product can be disposed of. 
• Share this notification with all potential device users of the device, including users at other locations. 
• Complete and return the customer response form included with the letter to smithsmedical6767@sedgwick.com within 10 days of receipt.
• DISTRIBUTORS: If affected products were distributed, immediately forward this notice and request the recipients complete the response form and return it.

Reason for Recall

Smiths Medical is recalling ORAL/NASAL Endotracheal Tubes after becoming aware that certain sizes of ORAL/NASAL Endotracheal Tube products may have a smaller diameter than expected. If the diameter of the device is smaller than expected, it may not provide enough ventilation to the patient.

The use of affected product may cause serious adverse health consequences, including lack of oxygen (hypoxia) that may to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death.  

There have been eight reported injuries. There have been no reports of death.

Device Use

ORAL/NASAL Endotracheal Tubes help keep air flowing through a patient’s airway. They are inserted in the mouth (oral) and/or the nose (nasal) when someone needs to be intubated to maintain airway patency and support ventilation.

Contact Information

Customers in the U.S. with questions about this recall should contact Smiths Medical at smithsmedical6767@sedgwick.com or 1-877-877-0317.

Full List of Affected Devices

Affected Products

Lots

100/105/025

3911500 4110012 4308451 3986480 4222894 4255323 3954958 4159071 3927026 4135634 4337267 4014665 4284465 4062708 4345413

100/105/030

3880748 4121698 3990354 3904782 4282245 4354054 6025898 6054524 3891668 4214842 4062709 3955939 4264607 6001192 4337268 6018580

100/105/035

3874397 4269334 3986481 3904795 4370803 4059423 6010588 4222896 3931215

100/111/020

3927050 4112845 4308454 3969650 4135636 4304616 4195285 4358010 4029076 4217899 4347850 4047362 4241691 4361583 4337269 3990360 4059424 4271735 4414897 4068624 4282247 4433466 3973460 4144618 4433467 4427307 4206539 4412425 6001190 6003054 6003050 6018576 6018589 4433469

100/111/025

3874369 4166621 4392320 3880750 4080553 4403653 4195302 4414383 3930096 4214848 4424550 3936648 4222902 4427318 4412427 3918122 3949085 4220271 4433469 3955901 4241695 4433470 3895055 4187126 3962938 4255331 4433471 3990368 4292828 4461704 3986487 4304618 4026789 4337270 6001189 4047364 4337271 6003050 4465594 4007486 4053371 4354057 6018576 4059426 4343025 4141293 4308455 6001190 4065680 4345418 4135622 4110009 4356222 4147623 4153140 4370806 4110010 4368783

100/111/030

3891574 4228827 4138429 3895035 4260297 4147624 4292829 4169644 3901349 4262331 4161530 3904790 3908090 4290034 4187132 3933578 3949086 4304621 4206541 3946325 4304620 4200189 4337276 4214850 3955988 4337275 4225676 3969651 4340965 4452151 3973463 4269339 4000829 4358015 4456323 4014666 4347854 4461702 4452150 3981461 4018136 4351770 4465589 4026786 4379014 6001208 4343026 4454684 4036208 4392322 4465590 4047356 4403654 6010602 4414889 4118068 4085821 4417662 4127351 4103890 4425920 4138428 6010603 4065678 4091975 4433473 4446988 4433474 6031562 6013487 4062712 4406592 4433472

100/111/035

3874375 4192162 4461701 3897982 4206542 4456324 4220276 6001197 3921049 4217903 6010605 3939719 4247562 6010606 4465586 3918158 3936640 4274653 6010608 3955906 4271738 6013488 3911479 4214852 3969652 4295329 6027710 3973454 4306894 6055167 4036210 4347856 4014667 4351771 4038587 4392324 4059427 4377386 4000831 4343030 4053384 4394899 4080556 4417660 4100450 4414384 3990363 4340968 4091976 4424548 4110003 4427310 4112854 4433476 4169636 4187134 4141294 4433475 4144599 4446989 4159072 4452143 4166606 4452144

100/126/025

3874389 3966169 4124776 4290040 4385674 4347863 4062719 4217908 3891578 3986493 4147630 4343051 4445290 4373213 4192138 3939723 3918145 4047359 4452134

100/126/030

3891631 4047361 4222910 4358021 4347864 6018600 4169648 4343053 3918169 4059422 4247568 4380606 4198116 4461697 4135632 4036209 3949087 4107078 4269345 4433492 4287239 4456321 3955961

100/126/035

3867283 4364622 4204344 4091971 3954950 4065676 3933571 6018590 3884332 4427325 4277416 4124773 4000836 4175618 4042230 4345430 3911489 4456327 4326705 4150620

100/127/025

3895053 4445291 4351776 4241703 4135609 6055170 4326704 4198085 3911512 4446994 4380607 4262334 4150621 3986494 6031543 4416396 3942625

100/127/030

3897978 4465579 4308456 3969659 3955989 4225686 6051961 4412423 3927028

100/127/035

3874374 3946346 4228833 4356229 4380608 6010610 3997428 4347866 3921055

100/141/025

3877721 4018140 4169669 4290041 4430791 4032458 4230673 4394925 3904766 4088780 4187130 4290042 4454685 3981483 3966170 4121693 3923790 4097361 4192164 4337277 4465596 4159074 6031570 6051980 3936661 4115482 4214857 4377393 6003052 4241704 4217909 4380610 3939725 4110011

100/141/030

3872612 3931212 4121704 4217911 4287243 4445297 4271747 4195299 3877722 3936629 4147632 4222912 4380611 4433497 4394926 4121706 3880755 3969660 4144626 4233557 4392329 4445299 4187158 4260304 3891596 3981479 4153129 4164141 4406609 4448467 4445296 4287242 3891597 4065679 4166602 4243803 4445295 4456314 4175579 4250644 3927046 4100443 4115490 6027719 6027720

100/141/035

3874416 4053381 4144612 4250647 4380612 4454686 4144611 4047360 3874417 4075491 4150624 4269347 4392331 4456315 4225683 4042224 3897969 4097371 4164146 4287244 4394927 6001193 3981482 4141279 3908113 4062721 4166604 4282270 4430792 6003053 4247572 6060009 3933576 4115492 4192135 4274658 4220291 6018577 4214860 4379007 3939726 4109996 4195273 4377394 4220289 6027730 3969662 4138434 4050233

Additional FDA Resources   

Additional Company Resources (listed in order of most to least recent):

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.