HXBL/WETEX/Genesis Biomedical Viral Transport Container — Class I medical device recall Z-1399-2022
Ongoing recall by Haimen Shengbang Laboratory Equipment Co. Ltd., reported 2022-08-17, distributed nationwide. Distributed VTM outside of VTM Guidance and without clearance.
| Recall number | Z-1399-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haimen Shengbang Laboratory Equipment Co. Ltd., Nantong, China |
| Recall initiated | 2022-07-12 |
| Classified | 2022-08-08 |
| Reported by FDA | 2022-08-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN |
| Quantity | 3,950,000 units |
| Model numbers | HX-K59-1 |
Product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Reason for recall
Distributed VTM outside of VTM Guidance and without 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-1399-2022. 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.