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
- 1,370
- Deaths
- 2
- Injuries
- 60
- Malfunctions
- 1,306
Reports per year
425
1,36626
Source: FDA adverse event reports by year received, 2025–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Set, Administration, IntravascularFPA1,143
- Tube Tracheostomy And Tube CuffJOH46
- Set, I.V. Fluid TransferLHI38
- Tube, Tracheal (W/Wo Connector)BTR29
- Tube, Tracheostomy (W/Wo Connector)BTO23
- Needle, Hypodermic, Single LumenFMI19
- Probe, Blood-Flow, ExtravascularDPT13
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT9
- Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA8
- Device, Warming. Blood And PlasmaKZL8
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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