FDA Device recall Z-0178-2022
Bivona Uncuffed Wire Endotracheal Tubes
- FDA Device
- Class II
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of Bivona Uncuffed Wire Endotracheal Tubes by Smiths Medical Asd, citing inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-09 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
Bivona Uncuffed Wire Endotracheal Tubes,
Reason
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Identifiers
| code_info | SKU 15W080 Lots #'s: 3221795, 3221796, 3226185, 3250343, 3263023, 3272646, 3301497, 3301498, 3312810, 3312811, 331572…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0178-2022%22
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