Smiths Medical Recalls Pediatric Tracheostomy Tubes Due to Packaging Error
Smiths Medical is recalling 20 pediatric tracheostomy tubes because one lot was packaged with the wrong size flange plate.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue is a packaging error involving the wrong size flange plate, which is a labeling/packaging defect rather than a direct contamination or structural failure leading to immediate severe injury.
Plain-English summary
Smiths Medical ASD Inc. is recalling 20 units of Pediatric Adjustable Flange Tracheostomy Tube Cuffless, Model 60HA30, Lot 3794165. The recall was initiated because one lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
The affected devices were distributed in the United States to Nebraska, Tennessee, Texas, and Mississippi, as well as internationally to France, Sweden, the United Arab Emirates, the United Kingdom, the Netherlands, Czechia, Australia, and Denmark.
Healthcare providers and consumers should stop using the affected devices and contact Smiths Medical for instructions on return or replacement.
The recalled product
- Product
- Pediatric Adjustable Flange Tracheostomy Tube Cuffless
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 20
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)
- Model Number: 60HA30
- Lot: 3794165
- SKU 60HA30
Distribution
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