CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
smiths medical portex, Nasopharyngeal Airway recalled
Smiths Medical ASD is recalling smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) Airway Nasopharyngeal. The recall was initiated on 18 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0143-2025
- FDA event ID
- 95181
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2024
- FDA classified
- 23 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Jul 2024 | Recall initiated by company | |
| 23 Oct 2024 | Classified by FDA | +97 days |
| 30 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Uncertainty in the seal integrity of the sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Uncertainty in the seal integrity of the sterile packaging.
Which lots are affected?
a) REF 100/210/060, UDI/DI 35019315010990, Lot Numbers: 4147817; UDI/DI 35019315011003, Lot Numbers: 4097683, 4100700; UDI/DI 35019315022399, Lot Numbers: 4089149, 4112945; UDI/DI 35019315022405, Lot Numbers: 4110350, 4115879, 4156815; UDI/DI 35019315022429, Lot Numbers: 4107296; b) REF 100/210/060JP, UDI/DI 35019315022399, Lot Numbers: 4089149, 4104268, 4107295, 4112945, 4133226, 4133228; c) REF 100/210/070, UDI/DI 35019315010952, Lot Numbers: 4147818, 4150795; UDI/DI 35019315010990, Lot Numbers: 4107293, 4122008; UDI/DI 35019315011003, Lot Numbers: 4107294, 4122007; UDI/DI 35019315018156, Lot Numbers: 4088214, 4088217, 4109288; UDI/DI 35019315022399, Lot Numbers: 4104268, 4115880; UDI/DI 35019315022405, Lot Numbers: 4097684, 4104267, 4110348, 4118571, 4156816; UDI/DI 35019315022429, Lot Numbers: 4092462, 4112944; UDI/DI 35019315022559, Lot Numbers: 4104266, 4110349; d) REF 100/210/070JP, UDI/DI 35019315022405, Lot Numbers: 4089150, 4092463, 4097684, 4104267, 4110348, 4110350, 4118570, 4118571, 4122011, 4122012, 4127688, 4133230, 4156815, 4156816; e) REF 100/210/080, UDI/DI 35019315022399, Lot Numbers: 4107295; UDI/DI 35019315011003, Lot Numbers: 4150794; UDI/DI 35019315018156, Lot Numbers: 4088216, 4109287, 4119724; UDI/DI 35019315022405, Lot Numbers: 4089150, 4092463, 4118570; f) REF 100/210/080JP: UDI/DI 35019315022429, Lot Numbers: 4092462, 4100701, 4107296, 4125005, 4127687, 4141737, 4147168; g) REF 100/210/080JS, UDI/DI 35019315022429, Lot Numbers: 4100701; h) REF 100/210/090, UDI/DI 35019315010952, Lot Numbers: 4092461; UDI/DI 35019315010990, Lot Numbers: 4089148; UDI/DI 35019315018156, Lot Numbers: 4109285, 4119729; UDI/DI 35019315022429, Lot Numbers: 4100701; UDI/DI 35019315022559, Lot Numbers: 4088205, 4118569; i) REF 100/210/090JP, UDI/DI 35019315022559, Lot Numbers: 4088205, 4104266, 4118569, 4133814, 4147169
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 95181This product is part of a recall event; the main page for the event is smiths medical portex, 'Orator' Speaking Valve For Tracheostomy Tube recalled.
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