Smiths Medical Nasal Cannula Recalled for Incorrect Labeling
Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error where dates are transposed, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Smiths Medical ASD Inc. is recalling 2,550 units of the Portex First Breath Adult Nasal Cannula (REF 001285). The product is used for the administration of nasal oxygen and humidity to patients. The recall involves devices with Lot number 1705151A.
The recall was initiated because the 'Manufactured' and 'Use By' labels on the packaging are transposed incorrectly. This labeling error suggests that the product expires before it was manufactured, which is a documentation and labeling defect.
The affected devices were distributed worldwide, including nationwide in the United States (AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV) and to Poland and Russia. The distribution included government channels but no military distribution. Consumers and healthcare facilities should stop using the affected devices and contact Smiths Medical ASD Inc. for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 2,550
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 (1)
- Lot number 1705151A
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 HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02