Smith & Nephew Medical Ltd.
FDA adverse event reports naming Smith & Nephew Medical Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SMITH & NEPHEW MEDICAL LTD..
- Total reports
- 9,231
- Deaths
- 11
- Injuries
- 2,713
- Malfunctions
- 6,503
Reports per year
Source: FDA adverse event reports by year received, 2007–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Negative Pressure Wound Therapy Powered Suction PumpOMP5,069
- Tape And Bandage, AdhesiveKGX2,006
- Lavage, JetFQH748
- Dressing, Wound, OcclusiveNAD734
- Dressing, Wound, DrugFRO179
- Bandage, ElasticFQM145
- Topical Approximation SystemMZR88
- Dressing, Wound And Burn, OcclusiveMGP69
- Dressing, Wound, HydrophilicNAC55
- Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE17
Recent recalls
- 2024-11-22Open, ClassifiedProcess control
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
- 2024-04-18Open, ClassifiedUnder Investigation by firm
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- 2024-04-18Open, ClassifiedUnder Investigation by firm
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
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