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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88512

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 09, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Bivona Aire-Cuf Endotracheal Tube

Z-0177-2022
Recall number
Z-0177-2022
Initiated
August 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
7136 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Inadequate pouch
Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.

device · product 2 of 2

Bivona Uncuffed Wire Endotracheal Tubes,

Z-0178-2022
Recall number
Z-0178-2022
Initiated
August 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
2191 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Inadequate pouch
Sterility assurance reason.sterility_assurance · v1.0.0
compromised sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Code information

SKU 15W080 Lots #'s: 3221795, 3221796, 3226185, 3250343, 3263023, 3272646, 3301497, 3301498, 3312810, 3312811, 3315720, 3315721, 3338833, 3346070, 3361916, 3370107, 3379478, 3433337, 3437237, 3442378, 3442379, 3451013, 3459483, 3463690, 3491443, 3491444, 3491445, 3491446, 3491447, 3491448, 3507938, 3507939, 3507940, 3507941, 3512284, 3512285, 3517254, 3521999, 3531347, 3540954, 3545300, 3552748, 3565644, 3569215, 3582745, 3608114, 3608131, 3615305, 3641651, 3680769, 3700904, 3707798, 3782473, 3790044, 3890025, 3890026, 3890027, 3890028, 3890029, 3890030, 3890031, 3890032, 3890033, 3907873, 3926897, 3985080 and 3991281. SKU 15W085 SKU 15W090 SKU 15W095

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.