PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2603-2024
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-2603-2024 |
|---|---|
| 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 | 15021312005905, 15021312005912, 15021312005929, 15021312005936 |
| Lot numbers | 3871033, 3871068, 3917999, 3930033, 3942447, 3949029, 3952405, 3965333, 4119099, 4119119, 4138994, 4139020, 4142429, 4159985, 4161958, 4161978, 4168187, 4171564, 4185397, 4197598, 4204800, 4213392, 4221322, 4267836, 4334857, 4334858, 4334859, 4334861, 4348373, 4348376, 4351228, 4374392, 4383590, 4389861 |
| Model numbers | 65N025, 65N030, 65N035, 65N040 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040
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-2603-2024. 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.