PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2607-2024
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-2607-2024 |
|---|---|
| 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 | 15021312006230 |
| Serial numbers | 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068 |
| Model numbers | 67N040 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
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-2607-2024. 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.