Ventana HE 600 System — Class II medical device recall Z-1374-2022
Ongoing recall by Ventana Medical Systems Inc, reported 2022-07-20, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical shor
| Recall number | Z-1374-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems Inc, Oro Valley, AZ, United States |
| Recall initiated | 2022-06-01 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, IE, IL, IT, JP, KR, KW, LB, LU, MY, NL, NO, PL, SA, SE, SG, SI, SK, SV, TH, TR, TW, VN |
| Quantity | 763 instruments |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04015630976010 |
Product
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Reason for recall
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
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-1374-2022. 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.