CLASS II ONGOING Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

BenchMark Ultra and Discovery Ultra Instruments recalled

Ventana Medical Systems is recalling BenchMark Ultra and Discovery Ultra Instruments, distributed in 52 states. The recall was initiated on 20 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers Less-Than-Or-Equal-To 322030

Quantity recalled9214

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0894-2022
FDA event ID: 89727
Recalling firm: Ventana Medical Systems, Oro Valley, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jan 2022
FDA classified: 7 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

20 Jan 2022	Recall initiated by company
7 Apr 2022	Classified by FDA	+77 days
13 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Where it was distributed

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, Belgium, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom, Algeria, Argentina, Aruba, Bosnia-Herzegovina., Brazil, Bulgaria, Chile, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Greece, Indonesia, Ireland, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Monaco, Morocco, Namibia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Reunion, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam, White Russia, Zimbabwe

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Serial Numbers Less-Than-Or-Equal-To 322030

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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17 Jun 2020Device	CLASS II	Model Number: 06917259001 UDI: 04015630976010 - Product Usage recalled	Ventana Medical Systems	Packaging Defects	Nationwide

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