PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2589-2024
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-2589-2024 |
|---|---|
| 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 |
| Quantity | 25,283 units |
| UPC / GTIN / UDI-DI | 15021312006407, 15021312006414, 15021312006421 |
| Lot numbers | 3710823, 3778495, 3778496, 3782548, 3789963, 3789964, 3789965, 3789966, 3790021, 3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3797124, 3797125, 3797136, 3797137, 3800590, 3800602, 3801380, 3801381, 3801535, 3801536, 3801537, 3801538, 3827976, 3827977, 3827978, 3827979, 3827980, 3827981, 3827982, 3827984, 3827985, 3827986, 3828066 and 226 more |
| Model numbers | 750160, 750170, 750180 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
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-2589-2024. 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.