FDA Device recall Z-2595-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025

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) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025 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-2595-2024
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) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786,… a) UDI/DI 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786, 3991203, 4015575, 4035758, 4083928, 4110465, 4156650, 4176238, 4209581, 4226268, 4254269, 4331631, 4335055, 4345041, 4348782, 4374468, 4374469, 4389923; b) UDI/DI 15021312005738, Product Code/List Number/Item Code 60P030, Lot Numbers: 3853478, 3868293, 3868294, 3884249, 3897861, 3904660, 3926961, 3936578, 3952364, 3952365, 3952366, 3959293, 3982699, 3997821, 4001215, 4011384, 4015576, 4024940, 4028385, 4040757, 4086004, 4092627, 4136145, 4145692, 4159935, 4185432, 4201393, 4206835, 4216332, 4216333, 4217450, 4223738, 4254270, 4273438, 4276478, 4286815, 4331632, 4335056, 4335057, 4374470, 4374471, 4382705, 4388203, 4389924, 4399210; c) UDI/DI 15021312005745, Product Code/List Number/Item Code 60P035, Lot Numbers: 3840043, 3853480, 3853481, 3864261, 3868247, 3871069, 3877659, 3880688, 3884267, 3891529, 3901310, 3904656, 3911424, 3920956, 3930014, 3939675, 3942522,

code_info

a) UDI/DI 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786,…

a) UDI/DI 15021312005721, Product Code/List Number/Item Code 60P025, Lot Numbers: 3880717, 3901307, 3939666, 3955786, 3991203, 4015575, 4035758, 4083928, 4110465, 4156650, 4176238, 4209581, 4226268, 4254269, 4331631, 4335055, 4345041, 4348782, 4374468, 4374469, 4389923; b) UDI/DI 15021312005738, Product Code/List Number/Item Code 60P030, Lot Numbers: 3853478, 3868293, 3868294, 3884249, 3897861, 3904660, 3926961, 3936578, 3952364, 3952365, 3952366, 3959293, 3982699, 3997821, 4001215, 4011384, 4015576, 4024940, 4028385, 4040757, 4086004, 4092627, 4136145, 4145692, 4159935, 4185432, 4201393, 4206835, 4216332, 4216333, 4217450, 4223738, 4254270, 4273438, 4276478, 4286815, 4331632, 4335056, 4335057, 4374470, 4374471, 4382705, 4388203, 4389924, 4399210; c) UDI/DI 15021312005745, Product Code/List Number/Item Code 60P035, Lot Numbers: 3840043, 3853480, 3853481, 3864261, 3868247, 3871069, 3877659, 3880688, 3884267, 3891529, 3901310, 3904656, 3911424, 3920956, 3930014, 3939675, 3942522,

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-2595-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.