PORTEX Bivona Tracheostomy Silicone Tube — Class I medical device recall Z-2606-2024
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-2606-2024 |
|---|---|
| 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 | 15021312006209, 15021312006216, 15021312006223 |
| Lot numbers | 3853378, 3868245, 3868286, 3884266, 3887733, 3894899, 3904655, 3918002, 3923736, 3939660, 3949047, 3952406, 3955773, 3961254, 3965335, 4011355, 4016045, 4016046, 4029491, 4043944, 4051629, 4060201, 4091408, 4113106, 4116109, 4128032, 4139007, 4148026, 4153599, 4156603, 4159991, 4171571, 4180470, 4185400, 4185401, 4216298, 4221331, 4237347, 4327886, 4327887 and 22 more |
| Model numbers | 67N025, 67N030, 67N035 |
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
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-2606-2024. 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.