Dewei DNA/RNA Preservation Kit — Class I medical device recall Z-0323-2023
Ongoing recall by DEWEI MEDICAL EQUIPMENT CO LTD, reported 2022-12-14, distributed in CA, FL, KY, MI. Products were distributed in the United States without FDA authorization or clearance.
| Recall number | Z-0323-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DEWEI MEDICAL EQUIPMENT CO LTD, Foshan, N/A, China |
| Recall initiated | 2022-08-09 |
| Classified | 2022-12-07 |
| Reported by FDA | 2022-12-14 |
| Distributed | CA, FL, KY, MI |
| Quantity | 1,348,000 |
| Lot numbers | DW200520, DW200628, DW201202, DW210103, DW210926 |
| Model numbers | DW-80005-1B |
Product
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Reason for recall
Products were distributed in the United States without FDA authorization or clearance.
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-0323-2023. 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.