3M Health Care
FDA adverse event reports naming 3M Health Care as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: 3M HEALTH CARE.
- Total reports
- 1,508
- Deaths
- 23
- Injuries
- 908
- Malfunctions
- 448
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Warmer, Blood, Non-Electromagnetic RadiationBSB281
- Tape And Bandage, AdhesiveKGX243
- Dressing, Wound, DrugFRO169
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI130
- Drape, Surgical, AntimicrobialKKX102
- Dressing, Wound, OcclusiveNAD76
- Electrode, ElectrocardiographDRX67
- System, Thermal RegulatingDWJ54
- Pad, Alcohol, Device DisinfectantLKB50
- Bandage, LiquidKMF41
Recent recalls
- 2003-12-18TerminatedOther
3M Attest 1264 Biological Indicators, in boxes of 100 per box
The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
- 2003-12-18TerminatedOther
3M Attest 1264P Biological Indicators, in boxes of 25 per box
The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
- 2003-05-16TerminatedOther
3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
- 2003-05-16TerminatedOther
3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ
The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
- 2003-04-22TerminatedOther
N/A
Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
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