Smiths Medical ASD Inc. Bivona Aire-Cuf Endotracheal Tube Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bivona Aire-Cuf Endotracheal Tube
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
3237504, 3263029, 3263030, 3267969, 3276517, 3276518, 3276519, 3301034, 3301035, 3301036, 3301479, 3307931, 3312816, 3312817, 3312818, 3312819, 3315710, 3315711, 3315712, 3346087, 3346088, 3349554, 3350510, 3350511, 3361918, 3361919, 3370120, 3370121, 3370122, 3379494, 3423620, 3433341, 3437242, 3437243, 3437244, 3437245, 3442385, 3450988, 3450989, 3451017, 3454875, 3454876, 3459488, 3459489, 3523718, 3528478, 3536391, 3536392, 3536393, 3536395, 3536398, 3536399, 3540955, 3541009, 3565654, 3572777, 3572790, 3577132, 3577134, 3577142, 3582755, 3582756, 3596290, 3604256, 3604272, 3608155, 3622333, 3622334, 3622336, 3630052, 3637293, 3656655, 3661490, 3661491, 3661492, 3664416, 3664417, 3677633, 3677634, 3677635, 3700907, 3700908, 3700909, 3700910, 3721738, 3721739, 3726299, 3730889, 3748028, 3890125, 3890127, 3890128, 3890129, 3890130, 3890131, 3890132, 3890133, 3890134, 3917895, 3917896, 3926899, 3926900, 3931090, 3933423, 3936455, 3952241, 3952242, 3952243, 3952244, 3952245, 3952246, 3955677, 3962474, 3985139, 3985140, 3985141, 3985142, 3985143, 3985144, 3985145, 3985146, 3991321, 3991322, 4026705, 4026706, 4039134, 4042021, 4042022, 4043952, 4043953, 4047982, 4060251, 4060252, 4063132, 3459490, 3463693, 3463694, 3463695, 3463696, 3472875, 3472876, 3484265, 3484266, 3484267, 3484273, 3484274, 3488047, 3504014, 3507849, 3512360, 3751160, 3751163, 3774410, 3778485, 3778493, 3782472, 3794166, 3800536, 3890117, 3890118, 3890119, 3890120, 3890121, 3890122, 3890123, 3890124, 4063133, 4063134, 4063135, 4063136, 4071990, 4071991, 4080805, 4080806, 4083993, 4089280, 4095958, 4097867, 4105268, 4105269, 3463693. SKU 35W085 Lots #'s: 3218553, 3230635, 3230636, 3238617, 3238618, 3258464, 3312935, 3346089, 3370123, 3437246, 3491405, 3507907, 3517266, 3540956, 3569173, 3590693, 3596299, 3608106, 3677631, 3748025, 3774374, 3870331, 3870332, 3890194, 3890195, 3890196, 3890197, 3901068, 3917865, 3929833, 3931093, 3948979, 3998080, 4015630, 4035792 and 4047987. SKU 35W090 Lots #'s: 3469110, 3904517, 4002358, 3504012, 3929861, 4002359, 3552747, 3959226, 4029451, 3700911, 3991328 and 4060253. SKU 35W095 Lots #'s: 3317880, 3839565, 4042023, 3360929 and 4035809
Products Sold
SKU 25W080 Lots #'s: 3648874 and 3890459 SKU 25W085 Lot # 3387669 SKU 25W090 Lots #'s 322657 and 3342023 SKU 25W095 SKU 35W080 Lots #'s: 3237503, 3237504, 3263029, 3263030, 3267969, 3276517, 3276518, 3276519, 3301034, 3301035, 3301036, 3301479, 3307931, 3312816, 3312817, 3312818, 3312819, 3315710, 3315711, 3315712, 3346087, 3346088, 3349554, 3350510, 3350511, 3361918, 3361919, 3370120, 3370121, 3370122, 3379494, 3423620, 3433341, 3437242, 3437243, 3437244, 3437245, 3442385, 3450988, 3450989, 3451017, 3454875, 3454876, 3459488, 3459489, 3523718, 3528478, 3536391, 3536392, 3536393, 3536395, 3536398, 3536399, 3540955, 3541009, 3565654, 3572777, 3572790, 3577132, 3577134, 3577142, 3582755, 3582756, 3596290, 3604256, 3604272, 3608155, 3622333, 3622334, 3622336, 3630052, 3637293, 3656655, 3661490, 3661491, 3661492, 3664416, 3664417, 3677633, 3677634, 3677635, 3700907, 3700908, 3700909, 3700910, 3721738, 3721739, 3726299, 3730889, 3748028, 3890125, 3890127, 3890128, 3890129, 3890130, 3890131, 3890132, 3890133, 3890134, 3917895, 3917896, 3926899, 3926900, 3931090, 3933423, 3936455, 3952241, 3952242, 3952243, 3952244, 3952245, 3952246, 3955677, 3962474, 3985139, 3985140, 3985141, 3985142, 3985143, 3985144, 3985145, 3985146, 3991321, 3991322, 4026705, 4026706, 4039134, 4042021, 4042022, 4043952, 4043953, 4047982, 4060251, 4060252, 4063132, 3459490, 3463693, 3463694, 3463695, 3463696, 3472875, 3472876, 3484265, 3484266, 3484267, 3484273, 3484274, 3488047, 3504014, 3507849, 3512360, 3751160, 3751163, 3774410, 3778485, 3778493, 3782472, 3794166, 3800536, 3890117, 3890118, 3890119, 3890120, 3890121, 3890122, 3890123, 3890124, 4063133, 4063134, 4063135, 4063136, 4071990, 4071991, 4080805, 4080806, 4083993, 4089280, 4095958, 4097867, 4105268, 4105269, 3463693. SKU 35W085 Lots #'s: 3218553, 3230635, 3230636, 3238617, 3238618, 3258464, 3312935, 3346089, 3370123, 3437246, 3491405, 3507907, 3517266, 3540956, 3569173, 3590693, 3596299, 3608106, 3677631, 3748025, 3774374, 3870331, 3870332, 3890194, 3890195, 3890196, 3890197, 3901068, 3917865, 3929833, 3931093, 3948979, 3998080, 4015630, 4035792 and 4047987. SKU 35W090 Lots #'s: 3469110, 3904517,4002358, 3504012, 3929861, 4002359, 3552747, 3959226, 4029451, 3700911, 3991328 and 4060253. SKU 35W095 Lots #'s: 3317880, 3839565, 4042023, 3360929 and 4035809
Smiths Medical ASD Inc. is recalling Bivona Aire-Cuf Endotracheal Tube due to Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Recommended Action
Per FDA guidance
Instructions to Consignees 1. Locate and quarantine affected product in your possession. 2. Determine the number of affected devices in your possession and complete the Response Form 3. All affected product must be returned to Sedgwick for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. Instructions to Distributors DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall and instruct them to return the Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026