PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2615-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2024-09-04. Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and
| Recall number | Z-2615-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2024-05-29 |
| Classified | 2024-08-23 |
| Reported by FDA | 2024-09-04 |
| UPC / GTIN / UDI-DI | 15021312000238, 15021312000245, 15021312000252, 15021312000269, 15021312000665, 15021312000696, 15021312000719, 15021312000726, 15021312000733, 15021312000740, 15021312000757 |
| Lot numbers | 3853432, 3853433, 3853435, 3853436, 3861151, 3861153, 3864230, 3868317, 3871054, 3871065, 3874295, 3874309, 3877644, 3877648, 3877649, 3880706, 3884258, 3887737, 3887752, 3887753, 3891531, 3891534, 3894891, 3894898, 3894900, 3897849, 3897862, 3897881, 3897882, 3897883, 3897884, 3901311, 3904678, 3907985, 3907988, 3907993, 3908000, 3908002, 3911438, 3917995 and 277 more |
| Model numbers | 67SN025, 67SN030, 67SN035, 67SN040, 67SP025, 67SP030, 67SP035, 67SP040, 67SP045, 67SP050, 67SP055 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055
Reason for recall
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2615-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.