PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2599-2024
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-2599-2024 |
|---|---|
| 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 | 15021312005837, 15021312005844, 15021312005851, 15021312005868, 15021312005875, 15021312005882, 15021312005899 |
| Lot numbers | 3835740, 3840084, 3840085, 3843107, 3843109, 3853454, 3853456, 3853457, 3853458, 3853462, 3853464, 3858172, 3868208, 3868209, 3868224, 3868288, 3868297, 3868298, 3868299, 3868300, 3868304, 3868305, 3868306, 3868307, 3868309, 3868310, 3868311, 3868320, 3871045, 3871052, 3871061, 3874291, 3874292, 3874293, 3874294, 3877642, 3877656, 3877657, 3877666, 3880702 and 460 more |
| Model numbers | 60PFS25, 60PFS30, 60PFS35, 60PFS40, 60PFS45, 60PFS50, 60PFS55 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
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-2599-2024. 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.