Bivona Aire-Cuf Endotracheal Tube — Class II medical device recall Z-0177-2022
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-0177-2022 |
|---|---|
| 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 | 7,136 devices |
| Reason classes | sterility, packaging |
| Lot numbers | 3218553, 322657, 3230635, 3230636, 3237503, 3237504, 3238617, 3238618, 3258464, 3263029, 3263030, 3267969, 3276517, 3276518, 3276519, 3301034, 3301035, 3301036, 3301479, 3307931, 3312816, 3312817, 3312818, 3312819, 3312935, 3315710, 3315711, 3315712, 3317880, 3342023, 3346087, 3346088, 3346089, 3349554, 3350510, 3350511, 3360929, 3361918, 3361919, 3370120 and 199 more |
Product
Bivona Aire-Cuf Endotracheal Tube
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-0177-2022. 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.