Ventana Medical Systems recalls

Ventana Medical Systems has 42 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 19 Aug 2026. 5 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls42since 2013

Last 12 months1reported

Class I3379% of total

Ongoing5latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 33 79%Class II 9 21%Class III 0 0%

Why ventana medical systems is recalled

Product types

By year

202612%
202412%
202312%
202225%
202012%
20183379%
201337%

Ongoing ventana medical systems recalls

5 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	navify Digital Pathology (on-prem) v2.5 recalled	Ventana Medical Systems	Device Malfunction	Nationwide
28 Aug 2024Device	CLASS II	Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody recalled	Ventana Medical Systems	Other	Nationwide
18 Jan 2023Device	CLASS II	Ventana Pd-L1 (SP142) Ventana Pd-L1 (SP142) Assay recalled	Ventana Medical Systems	Potency & Assay	Nationwide
20 Jul 2022Device	CLASS II	Ventana HE 600 System, automated slide preparer, for use recalled	Ventana Medical Systems	Packaging Defects	35 states
13 Apr 2022Device	CLASS II	BenchMark Ultra and Discovery Ultra Instruments recalled	Ventana Medical Systems	Packaging Defects	52 states

All ventana medical systems recalls, newest first

42 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	navify Digital Pathology (on-prem) v2.5 recalled	Ventana Medical Systems	Device Malfunction	Nationwide
28 Aug 2024Device	CLASS II	Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody recalled	Ventana Medical Systems	Other	Nationwide
18 Jan 2023Device	CLASS II	Ventana Pd-L1 (SP142) Ventana Pd-L1 (SP142) Assay recalled	Ventana Medical Systems	Potency & Assay	Nationwide
20 Jul 2022Device	CLASS II	Ventana HE 600 System, automated slide preparer, for use recalled	Ventana Medical Systems	Packaging Defects	35 states
13 Apr 2022Device	CLASS II	BenchMark Ultra and Discovery Ultra Instruments recalled	Ventana Medical Systems	Packaging Defects	52 states
17 Jun 2020Device	CLASS II	Model Number: 06917259001 UDI: 04015630976010 - Product Usage recalled	Ventana Medical Systems	Packaging Defects	Nationwide
26 Sep 2018Device	CLASS I	OptiView DAB IHC Detection Kit recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	CINtec p16 Histology (250) CE recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	ISH iVIEW Blue Plus Detection Kit recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Confirm anti-Estrogen Receptor (ER) recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	ultraView SISH DNP Detection Kit recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	ultraView Universal DAB Detection Kit recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	CINtec p16 Histology (250) recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Ventana Basal Cell Cktl, (34BE12+p63)250 recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	ultraView Universal Alkaline Phosphatase Red Detection Kit recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	OptiView Amplification Kit (250 test) recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	ultraView SISH DNP Detection Kit US recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Confirm anti-Progesterone Receptor (PR) recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Nexes Ven Iview Dab Det Kt Jpn-us Export recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	ISH Protease recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	CINtec Histology (250) recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	iView DAB Detection Kit w/o Secondary Antibody recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Ventana ISH iView Blue Detection Kit recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Anti-pan Keratin Primary Antibody recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	iView DAB Detection Kit recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Ventana anti-Helicobacter Pylori (SP48) PAB recalled	Ventana Medical Systems	Packaging Defects	AZ
26 Sep 2018Device	CLASS I	Inform HPV III Fam 16 Probe - US Export recalled	Ventana Medical Systems	Packaging Defects	AZ
7 Mar 2018Device	CLASS I	ultraView SISH Detection Kit, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018Device	CLASS I	OptiView DAB IHC Detection Kit, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018Device	CLASS I	OptiView Amplification Kit (250 Test), Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.