Pediatric Adjustable Flange Tracheostomy Tube Cuffless — Class II medical device recall Z-2485-2020
Terminated recall by Smiths Medical ASD Inc., reported 2020-07-08, distributed in MS, NE, TN, TX. One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged wi
| Recall number | Z-2485-2020 |
|---|---|
| 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 | 2020-05-26 |
| Classified | 2020-07-01 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2021-05-05 |
| Distributed | MS, NE, TN, TX |
| Countries outside the US | AE, AU, CZ, DK, FR, GB, NL, SE |
| Quantity | 20 devices |
| Lot numbers | 3794165 |
| Model numbers | 60HA30 |
Product
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Reason for recall
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
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-2485-2020. 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.