Portex Blue Line Ultra Tracheostomy Tube Inner Cannula — Class II medical device recall Z-1732-2019
Terminated recall by Smiths Medical ASD Inc., reported 2019-06-12, distributed nationwide. Packaged with an incorrect size inner cannula.
| Recall number | Z-1732-2019 |
|---|---|
| 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 | 2019-02-11 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IE |
| Quantity | 7,840 |
| Lot numbers | 3578884 |
Product
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
Reason for recall
Packaged with an incorrect size inner cannula.
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-1732-2019. 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.