Tracheostomy Tube Flange May Tear Due to Manufacturing Defect
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. This affects pediatric and adult sizes distributed worldwide.
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. The source text does not report deaths or injuries, which would otherwise indicate a Critical score. The manufacturing defect affects a critical component of an airway device, consistent with Severe classification.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes, available in sizes 4.0MM, 4.5MM, 5.0MM, 5.5MM, and 6.0MM for pediatric and adult patients.
The securement flange of these tubes may tear due to a manufacturing defect. The flange is a critical component that holds the tracheostomy tube securely in place.
These tubes have been distributed worldwide. Affected lot numbers for each product size are identified by UDI number and are listed on the FDA recall notice.
Patients and healthcare providers should contact Smiths Medical or the FDA with any questions or to report adverse events. Healthcare facilities should review their inventory to identify whether affected lots are in use.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- flange-tear
- manufacturing-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)
- a) UDI/DI 15021312516838
- Product Code/List Number/Item Code 60PFPS40
- Lot Numbers: 3853451
- 3853452
- 3868260
- 3877673
- 3884242
- 3894866
- 3907983
- 3917997
- 3920962
- 3920963
- 3930049
- 3930050
- 3942548
- 3942549
- 3959326
- 3959327
- 3959328
- 3991154
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- 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
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03