PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2601-2024
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-2601-2024 |
|---|---|
| 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 | 15021312516760, 15021312516777, 15021312516784, 15021312516791, 15021312516807, 15021312516814 |
| Lot numbers | 3840057, 3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3853472, 3853473, 3853474, 3858171, 3861148, 3863922, 3864208, 3868198, 3868199, 3868215, 3868216, 3868217, 3868218, 3868220, 3868221, 3868222, 3868230, 3868234, 3868235, 3868236, 3868237, 3868238, 3868239, 3868241, 3868242, 3868243, 3868244, 3868324, 3868325, 3871032, 3871034, 3871035, 3871051 and 460 more |
| Model numbers | 60PFSS30, 60PFSS35, 60PFSS40, 60PFSS45, 60PFSS50, 60PFSS55 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
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-2601-2024. 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.