PORTEX Bivona Tracheostomy Tube Securement Flange May Tear Due to Manufacturing Defect
Smiths Medical recalls specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially affecting tube positioning.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. This designation reflects the seriousness of a manufacturing defect affecting a critical airway management device.
Plain-English summary
PORTEX Bivona Tracheostomy Tubes are used to maintain open airways in patients. Smiths Medical ASD Inc. is recalling specific lots because the securement flange may tear due to a manufacturing defect.
A securement flange holds the tube in position. If it tears, the tube may not stay properly secured, which is critical for patient safety. The affected devices have been distributed worldwide.
Patients, caregivers, and healthcare providers should immediately stop using affected tubes and contact their healthcare provider to obtain replacement devices. The FDA has classified this as a Class I recall. Specific affected serial numbers are listed in the FDA recall notice.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
- Manufacturer
- Smiths Medical ASD Inc.
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 (20)
- UDI/DI 15021312516821
- Product Code/List Number/Item Code 60PFP60
- Serial Numbers: 3853449
- 3880705
- 3887741
- 3894904
- 3897853
- 3918010
- 3920943
- 3926956
- 3942473
- 3942474
- 3962604
- 3982663
- 3982664
- 3991153
- 4015523
- 4026688
- 4033722
- 4035735
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 28 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 28 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 · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSmiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2021-01-06
- HighSmiths Medical Recalls Bivona Cuffless FlexTend Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2021-03-03
- ModerateSmiths Medical Recalls Pediatric Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2020-07-08
- HighBivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier
FDA (Devices) · 2021-11-03
- SevereSmiths Medical Tracheostomy Tubes Recalled Due to Pilot Balloon Disconnection Risk
FDA (Devices) · 2024-09-18
- ModerateSmiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes
FDA (Devices) · 2017-03-22