Browse Device Recalls
39 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 1, 2022 | Ventana HE 600 System, automated slide preparer, for use in laboratories. | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in e... | Class II | Ventana Medical Systems Inc |
| Jan 20, 2022 | BenchMark ULTRA and DISCOVERY ULTRA Instruments | Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of... | Class II | Ventana Medical Systems Inc |
| Oct 4, 2019 | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System... | The firm became aware of a cleaning solution leaking issue from the middle staining module of the... | Class II | Ventana Medical Systems Inc |
| Aug 2, 2018 | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody,... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immun... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 7... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-09... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antib... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 76... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistoche... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohi... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, M... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-0... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 7... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohis... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 80... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 0527196... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMM... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI ... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 063965180... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 059... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche G... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche ... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitr... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Dec 19, 2017 | ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GM... | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... | Class I | Ventana Medical Systems Inc |
| Sep 28, 2012 | VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear... | Potiential for a waste fluid overflow condition to accur while running decontamination cycles on ... | Class II | Ventana Medical Systems Inc |
| Sep 28, 2012 | VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Resear... | Potential for a waste fluid overflow condition to accur while running decontamination cycles on t... | Class II | Ventana Medical Systems Inc |
| Jun 12, 2008 | Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS... | Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments... | Class II | Ventana Medical Systems Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.