Smiths Medical ASD, Inc. medical device recall: Portex Endotracheal Tube
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96263
- Recall initiated
- Feb 13, 2025
- Classified by FDA
- Mar 12, 2025
- Posted in Enforcement Report
- Mar 19, 2025
- Recalling firm
- Smiths Medical ASD, Inc.
- Firm location
- Minneapolis, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 13, 2025. FDA classified it 27 days later, on Mar 12, 2025. Distribution reported by FDA: Worldwide - US Nationwide distribution. Smiths Medical ASD, Inc. has 108 recalls in our records.
Recalled products (1)
Z-1289-2025 Class I Ongoing
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
Codes / lots: 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…
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96263
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.