Smiths Medical Portex Nasal Oxygen Cannula Recall for Labeling Error
Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, and the source text identifies the issue as a labeling error (transposed dates) rather than a physical defect or contamination, which aligns with the rubric for cosmetic or documentation issues.
Plain-English summary
Smiths Medical ASD Inc. is recalling 13,750 units of the Portex First Breath Nasal Oxygen Cannula, REF 001292. The affected devices include a Gas Monitoring Line, Male Luer Connector, Tubing, and Oxygen Adapter. The product is used for the administration of nasal oxygen and humidity to patients.
The recall was initiated because the 'Manufactured' and 'Use By' labels on the product are transposed incorrectly. This labeling error suggests that the product expires before it was manufactured. The affected lot numbers are 1702231A, 1703231A, and 1705163A.
The devices were distributed worldwide, including nationwide in the United States in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. Distribution also occurred in Poland and Russia. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 13,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers 1702231A
- 1703231A
- and 1705163A
Distribution
Part of a larger recall action
This product is one of 5 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSmiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size
FDA (Devices) · 2019-06-12
- HighSmiths Medical Portex Nasopharyngeal Airway recalled for sterile packaging seal integrity uncertainty
FDA (Devices) · 2024-10-30
- SevereSmiths Medical Recalls Mislabelled Portex Low Dead Space Connectors
FDA (Devices) · 2014-06-18
- ModerateSPS Sterilization Recalls Edwards Lifesciences Aortic Cannula Due to Labeling Error
FDA (Devices) · 2018-09-19
- ModerateSalter Labs Recalls Oxygen Masks Due to Incorrect Labeling
FDA (Devices) · 2014-07-30
- High3B Medical Oxygen Cannula Recall: Units Shipped After Expiration Date
FDA (Devices) · 2025-01-15