Cannula, Nasal, Oxygen
FDA adverse event reports and recall history for cannula, nasal, oxygen (product code CAT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,758
- Deaths
- 30
- Injuries
- 203
- Malfunctions
- 1,463
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- TerminatedLabeling design
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- TerminatedLabeling design
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- TerminatedLabeling design
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- TerminatedLabeling design
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- TerminatedLabeling design
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- TerminatedUnknown/Undetermined by firm
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
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