Smiths Healthcare Manufacturing S.A. DE C.V.
FDA adverse event reports naming Smiths 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: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V..
- Total reports
- 3,199
- Deaths
- 9
- Injuries
- 199
- Malfunctions
- 2,986
Reports per year
105
1506
2807
7608
3409
117
220
521
522
5823
1,23524
1,53325
20626
Source: FDA adverse event reports by year received, 2005–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Set, Administration, IntravascularFPA1,487
- Tube, Tracheal (W/Wo Connector)BTR396
- Tube Tracheostomy And Tube CuffJOH347
- Probe, Blood-Flow, ExtravascularDPT185
- Tube, Tracheostomy (W/Wo Connector)BTO124
- Warmer, Thermal, Infusion FluidLGZ110
- Device, Warming. Blood And PlasmaKZL88
- Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI72
- Set, I.V. Fluid TransferLHI67
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT59
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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