FDA Device recall Z-2603-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025
- FDA Device
- Class I
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class I recall of PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025 by Smiths Medical Asd, citing 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 defe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2603-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-29 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
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
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.
Identifiers
| code_info | a) UDI/DI 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers: 3949029, 4138994, 4171564, 4334857,…a) UDI/DI 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers: 3949029, 4138994, 4171564, 4334857, 4383590; b) UDI/DI 15021312005912, Product Code/List Number/Item Code 65N030, Lot Numbers: 3917999, 3965333, 4142429, 4161978, 4185397, 4197598, 4334858, 4348373; c) UDI/DI 15021312005929, Product Code/List Number/Item Code 65N035, Lot Numbers: 3871033, 3930033, 3942447, 4119099, 4139020, 4159985, 4168187, 4204800, 4213392, 4334859, 4351228, 4374392, 4389861; UDI/DI 15021312005936, Product Code/List Number/Item Code 65N040, Lot Numbers: 3871068, 3952405, 4119119, 4161958, 4221322, 4267836, 4334861, 4348376 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2603-2024%22
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