Smiths Medical International, Ltd.
FDA adverse event reports naming Smiths Medical International, Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SMITHS MEDICAL INTERNATIONAL, LTD..
- Total reports
- 3,709
- Deaths
- 10
- Injuries
- 437
- Malfunctions
- 3,260
Reports per year
2210
1711
1312
1213
1414
415
8016
217
1218
319
23320
43321
1,67922
1,17423
324
Source: FDA adverse event reports by year received, 2010–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Tube, Tracheostomy (W/Wo Connector)BTO1,076
- Tube, Tracheal (W/Wo Connector)BTR839
- Ventilator, Emergency, Powered (Resuscitator)BTL781
- Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI354
- Tube Tracheostomy And Tube CuffJOH260
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)CBI58
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ57
- Filter, Bacterial, Breathing-CircuitCAH32
- Anesthesia Conduction KitCAZ26
- Transducer, Blood-Pressure, ExtravascularDRS25
Recent recalls
- 2005-07-07TerminatedOther
Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
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