Skip to content
Use caution Medical device recall · FDA · Published January 20, 2022

Ventana BenchMark Ultra and Discovery Ultra Instruments Recall: Fluid Leak Risk

Ventana Medical Systems recalls BenchMark Ultra and Discovery Ultra instruments with serial numbers <= 322030 due to potential fluid leaks causing electrical shorts and fire risks.

🇺🇸 FDA recall #Z-0894-2022Medical deviceVentana Medical Systems ›
Take action

Contact the company

Recalling firmVentana Medical Systems Inc1910 E Innovation Park Dr · Oro Valley, AZ 85755-1962
✎ GovInfoNow plain-language explainer

Ventana Medical Systems is recalling BenchMark Ultra and Discovery Ultra instruments with serial numbers up to 322:030 because fluid leaks inside the staining system could cause electrical shorts, smoke, and fire. This affects medical devices used in labs that handle tissue samples. Read more at govinfonow.com/recall/61240-ventana-benchmark-ultra-and-discovery-ultra-instruments-recall-fluid-leak.

Source Summary by GovInfoNow · govinfonow.com/recall/61240-ventana-benchmark-ultra-and-discovery-ultra-instruments-recall-fluid-leak · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0894-2022

Cite this page

“Ventana BenchMark Ultra and Discovery Ultra Instruments Recall: Fluid Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61240-ventana-benchmark-ultra-and-discovery-ultra-instruments-recall-fluid-leak. Based on FDA recall #Z-0894-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0894-2022%22&limit=1).

The FDA announced on Jan. 20, 2022, that Ventana Medical Systems Inc. is recalling BenchMark ULTRA and DISCOVERY ULTRA Instruments due to a potential fluid leak that could cause an electrical short circuit, smoke, and fire. Owners should contact the company for remedies.

How to tell if you have it

  • Brand: Ventana Medical Systems
  • Products: BenchMark ULTRA and DISCOVERY ULTRA Instruments
  • Serial Numbers: Less-Than-Or-Equal-To 322030

The hazard

The recall addresses a 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. This malfunction could result in smoke and fire, according to the FDA.

Context

GovInfoNow's records show Ventana Medical Systems, Inc. has 7 other recalls on record since Dec. 19, 2017. Other recent recalls of similar products include Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall (April 20, 2026), Ventana anti-CD10 antibody recall (June 27, 2024), and Ventana PD-L1 (SP142) Assay Recall (Nov. 18, 2022).

How to tell if you have this one

Check the serial number on the instrument. The recalled units have serial numbers less than or equal to 322030. These instruments are used in medical labs for tissue staining.

  • Brand
    Ventana Medical Systems
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Identify the serial number on the instrument to confirm if it is less than or equal to 322030.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND, IN, TX, TN, CT, SC, GA, UT, WI, VA, SD, KY, MS, MO, DE, MI, MT, NJ, WV, OK, WA, OR, PR, DC, NM, ID, NH, NE, ME, KS, HI, NV, RI, WY, VT OUS: Australia, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jan 20, 202212. FDA classified it Class II: Apr 7, 202223. Published in FDA’s Enforcement Report: Apr 13, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using the instrument immediately?

No immediate stop is required, but you should check the serial number and take action if it falls within the recalled range.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0894-2022 (January 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0894-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA