PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2604-2024
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-2604-2024 |
|---|---|
| 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 | 15021312005943, 15021312005950, 15021312005967, 15021312005974, 15021312005981, 15021312005998, 15021312006001 |
| Lot numbers | 3840082, 3853369, 3864229, 3868226, 3868312, 3868319, 3871030, 3871031, 3871043, 3871044, 3871060, 3880701, 3887746, 3897888, 3901291, 3904666, 3904668, 3904681, 3904682, 3908001, 3911435, 3920948, 3923718, 3923722, 3926980, 3926981, 3930040, 3930042, 3931150, 3933472, 3942462, 3942463, 3942471, 3942487, 3942493, 3950391, 3952341, 3952347, 3955805, 3955807 and 102 more |
| Model numbers | 65P025, 65P030, 65P035, 65P040, 65P045, 65P050, 65P055 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
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-2604-2024. 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.