FDA Device recall Z-2599-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/It…

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 STANDARD FLEXTEND PLUS , Product Code/List Number/It… 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-2599-2024
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 STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers: 3868288, 3901288, 3917984, 3942491… a) UDI/DI 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers: 3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474; b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers: 3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668; c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers: 3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702,

code_info

a) UDI/DI 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers: 3868288, 3901288, 3917984, 3942491…

a) UDI/DI 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers: 3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474; b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers: 3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668; c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers: 3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702,

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-2599-2024%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.