MeritMedical Cultura Flex Swab — Class II medical device recall Z-0454-2021
Terminated recall by Merit Medical Systems, Inc., reported 2020-11-25, distributed nationwide. The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This c
| Recall number | Z-0454-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2020-09-16 |
| Classified | 2020-11-16 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2021-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CO, GH, IE, JM, KE, PA, QA, TT |
| Quantity | 3,385,442 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884450491102, 10884450491109, 20884450491106 |
| Model numbers | C100F |
Product
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Reason for recall
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
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-0454-2021. 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.