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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- manufacturing-defect
- securement-defect
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03