Bivona¿ TTS — Class II medical device recall Z-1465-2017
Terminated recall by Smiths Medical ASD Inc., reported 2017-03-22, distributed in CA, CO, CT, FL, GA, LA, MA, MD…. Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was inco
| Recall number | Z-1465-2017 |
|---|---|
| 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 | 2017-02-09 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-06-20 |
| Distributed | CA, CO, CT, FL, GA, LA, MA, MD, MI, MN, MO, NC, NE, OK, PA, SC, TN, TX, WA, WI |
| Quantity | 142 |
| Reason classes | labeling |
| Model numbers | 67SP035 |
Product
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Reason for recall
Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.
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-1465-2017. 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.