Recall archive / FDA device enforcement

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N... — FDA record Z-2605-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055
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.
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: Not supplied
Agency-reported status: Ongoing
Source record identifier: Z-2605-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers: 4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388; b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers: 3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123; c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers: 3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390; d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers: 4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206; e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers: 4016047, 4016048, 4213398, 4221327,15021312000276, 4344963, 4348391, 4388093, 4389864; f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers: 4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392; g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers: 3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865; h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers: 3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534; i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers: 3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124; j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers: 3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125; k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers: 3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066

Label field

Details supplied by the agency

Lot, code or applicability

a) UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers: 4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388; b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers: 3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123; c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers: 3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390; d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers: 4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206; e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers: 4016047, 4016048, 4213398, 4221327,15021312000276, 4344963, 4348391, 4388093, 4389864; f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers: 4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392; g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers: 3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865; h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers: 3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534; i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers: 3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124; j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers: 3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125; k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers: 3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Sep 4, 2024
Recall initiation date: May 29, 2024
Center classification date: Aug 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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