Bivona Uncuffed Wire Endotracheal Tubes — Class II medical device recall Z-0178-2022
Terminated recall by Smiths Medical ASD Inc., reported 2021-11-03, distributed nationwide. Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
| Recall number | Z-0178-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2021-08-09 |
| Classified | 2021-10-27 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2023-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA, DE, DK, GB, IT |
| Quantity | 2,191 devices |
| Reason classes | sterility, packaging |
| Lot numbers | 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 and 27 more |
Product
Bivona Uncuffed Wire Endotracheal Tubes,
Reason for recall
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0178-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.