Bivona¿ Tracheostomy Tube Tracheostomy Tubes — Class II medical device recall Z-2114-2018
Terminated recall by Smiths Medical ASD Inc., reported 2018-06-13, distributed in CA, FL, GA, ID, NJ, NM, OH, VA. Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
| Recall number | Z-2114-2018 |
|---|---|
| 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 | 2018-04-02 |
| Classified | 2018-06-07 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2018-11-14 |
| Distributed | CA, FL, GA, ID, NJ, NM, OH, VA |
| Countries outside the US | FR |
| Quantity | 16 units |
| Reason classes | labeling, sterility |
| Lot numbers | AA16ES70NSC110N, AT17IS60NGC105N, CMZ3241N, CMZ3331N, FT16IN60NGC053N, FT17IN60NGC114N, FT17IN70NSC111N, FU15AN55NSA076N, ST16EN80NSC194N, SU15AN70NSC153N, XU17GS50NSF046N |
| Model numbers | AA16ES70NSC110N, AT17IS60NGC105N, CMZ3241N, CMZ3331N, FT16IN60NGC053N, FT17IN60NGC114N, FT17IN70NSC111N, FU15AN55NSA076N, ST16EN80NSC194N, SU15AN70NSC153N, XU17GS50NSF046N |
Product
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Reason for recall
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
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-2114-2018. 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.