smiths medical portex Tracheal Intubation Stylet — Class II medical device recall Z-2401-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-09-08. The incorrect device is contained in the package.
| Recall number | Z-2401-2021 |
|---|---|
| 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 | 2021-08-04 |
| Classified | 2021-09-01 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2025-03-11 |
| Countries outside the US | CA, ES, ID, JP |
| Quantity | 1,590 units |
| Lot numbers | 4015424 |
| Model numbers | 10/BOX, 100/120/200, 335MM, 4.0MMOD |
Product
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Reason for recall
The incorrect device is contained in the package.
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-2401-2021. 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.