Recall archive / FDA device enforcement
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) A... — FDA record Z-0143-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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;
- Reason
- Uncertainty in the seal integrity of the sterile packaging.
- Classification
- Class II
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 251,591 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0143-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 30, 2024
- Recall initiation date
- Jul 18, 2024
- Center classification date
- Oct 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.