Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-0178-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Bivona Uncuffed Wire Endotracheal Tubes,

Product Classification:

Class II

Date Initiated: August 9, 2021

Date Posted: November 3, 2021

Recall Number: Z-0178-2022

Event ID: 88512

Reason for Recall:

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

Status: Terminated

Product Quantity: 2191 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated