Portex Endotracheal Tube
Medical device recall Z-1289-2025. Published in FDA’s Enforcement Report on Mar 19, 2025.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 19, 2025. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
100/105/025 UDI-DI 15019315018633, Lots 3877711 3911500 3927026 3954958 3969644 3986480 4014665 4050235 4062708 4080550 4110012 4135634 4147621 4159071 4166635 4190224 4209071 4222894 4247556 4255323 4284465 4296990 4308451 4337267…
Every code shown here, 1,998 characters
100/105/025 UDI-DI 15019315018633, Lots 3877711 3911500 3927026 3954958 3969644 3986480 4014665 4050235 4062708 4080550 4110012 4135634 4147621 4159071 4166635 4190224 4209071 4222894 4247556 4255323 4284465 4296990 4308451 4337267 4345413; 100/105/030 UDI-DI 15019315018640, Lots 3880748 3891668 3904782 3931190 3942650 3969646 3990354 4004638 4011059 4050237 4059417 4062709 4077446 4091972 4121698 4144606 4153143 4166633 4192137 4214842 4247557 4255324 4264607 4282245 4304610 4337268 4343014 4345414 4354054 6001192 6010589 6018580 6025898 6054524 6055172; 100/105/030 15019315018640 3955939 100/105/035 15019315018657 3874397 3901353 3904795 3931215 3954951 3973457 3986481 4007482 4023465 4059423 4121695 4150613 4190222 4222896 4269334 4308452 4340958 4347847 4370803 6010588 6059989 100/105/035** 15019315018657 3955939 100/111/020 15019315018831 3884360 3927050 3936628 3969650 3973460 3990360 4018131 4029076 4036214 4047362 4053374 4059424 4068624 4080552 4085815 4110000 4112845 4135636 4144618 4166622 4187114 4195285 4206539 4217899 4241691 4255329 4260296 4271735 4279639 4282246 4282247 4304616 4308454 4337269 4347850 4358010 4361583 4377379 4412425 4414897 4417663 4427307 4433466 4433467 4461705 6003054 6018589 100/111/025 15019315018848 3874369 3880750 3895055 3918122 3930096 3936648 3949085 3955901 3962938 3986487 3990368 4007485 4007486 4018135 4026789 4042235 4047364 4053371 4059426 4065680 4080553 4110009 4110010 4135622 4141293 4147623 4153140 4166621 4187126 4195302 4214848 4220271 4222902 4241695 4255331 4290031 4292828 4296992 4304618 4308455 4337270 4337271 4343025 4345418 4354057 4356222 4368783 4370806 4392320 4403653 4406591 4412427 4414383 4424550 4427318 4433469 4433470 4433471 4461704 4465594 6001189 6001190 6003050 6003051 6010585 6018574 6018575 6018576 6027727 6031566 6031568 6051973 6051974 6055166 6055174 100/111/030 15019315018855 3891574 3895035 3901349 3904790 3908090 3930098 3933578 3946325 3949086 3955988 3969651 3973463 3981461 3990362…
FDA’s list runs to 5,764 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 13, 2025.
- FDA classified it on Mar 12, 2025.
- FDA’s Enforcement Report published it on Mar 19, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smiths Medical ASD, Inc., of Minneapolis, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,764 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.