ICU Medical Healthcare Manufacturing S.A. DE C.V.
FDA adverse event reports naming ICU Medical Healthcare Manufacturing S.A. DE C.V. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V..
- Total reports
- 2,310
- Deaths
- 2
- Injuries
- 60
- Malfunctions
- 2,248
Reports per year
1324
43125
1,86626
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Set, Administration, IntravascularFPA1,663
- Set, I.V. Fluid TransferLHI253
- Tube, Tracheal (W/Wo Connector)BTR136
- Tube Tracheostomy And Tube CuffJOH80
- Tube, Tracheostomy (W/Wo Connector)BTO42
- Device, Warming. Blood And PlasmaKZL19
- Warmer, Thermal, Infusion FluidLGZ14
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT14
- Probe, Blood-Flow, ExtravascularDPT11
- Tubing, Fluid DeliveryFPK11
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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