PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2594-2024
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-2594-2024 |
|---|---|
| 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 |
| Quantity | 36,219 units |
| UPC / GTIN / UDI-DI | 15021312516685, 15021312516692, 15021312516708 |
| Lot numbers | 3853441, 3853442, 3853443, 3853444, 3868200, 3868206, 3868207, 3868233, 3871058, 3871067, 3874303, 3877651, 3877653, 3884262, 3887742, 3887743, 3887749, 3894902, 3897854, 3901298, 3904673, 3904675, 3907991, 3907995, 3911432, 3918014, 3920946, 3926957, 3926968, 3930007, 3933475, 3939636, 3939665, 3942472, 3942534, 3946282, 3946283, 3946286, 3949020, 3952348 and 159 more |
| Model numbers | 60NFPS30, 60NFPS35, 60NFPS40 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
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-2594-2024. 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.