BenchMark ULTRA and DISCOVERY ULTRA Instruments — Class II medical device recall Z-0894-2022

Ongoing recall by Ventana Medical Systems Inc, reported 2022-04-13, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General

Recall number	`Z-0894-2022`
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	2022-01-20
Classified	2022-04-07
Reported by FDA	2022-04-13
Distributed	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the US	AE, AR, AT, AU, AW, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JP, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VN, ZA
Quantity	9,214
Reason classes	packaging, device malfunction
Serial numbers	`322030`

Product

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Reason for recall

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke 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-0894-2022. 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.