Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is… — Class II medical device recall Z-2946-2020
Terminated recall by Smiths Medical ASD Inc., reported 2020-09-16. Label has the incorrect size for the tracheotomy tube.
| Recall number | Z-2946-2020 |
|---|---|
| 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 | 2020-08-28 |
| Classified | 2020-09-09 |
| Reported by FDA | 2020-09-16 |
| Terminated | 2021-05-13 |
| Quantity | 3 units |
| Reason classes | labeling |
| Lot numbers | 3952216 |
Product
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Reason for recall
Label has the incorrect size for the tracheotomy tube.
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-2946-2020. 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.