Unknown Manufacturer
FDA adverse event reports naming Unknown Manufacturer as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: UNKNOWN MANUFACTURER.
- Total reports
- 3,117
- Deaths
- 28
- Injuries
- 3,087
- Malfunctions
- 2
Reports per year
812
413
2014
615
6716
30217
65118
83319
51720
24021
17922
12823
2724
6625
6026
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Breast, Inflatable, Internal, SalineFWM2,273
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR689
- Implant, Dermal, For Aesthetic UseLMH107
- Tissue Expander And AccessoriesLCJ42
- Mesh, SurgicalFTM5
- Implant, Eye ValveKYF1
- Mesh, Surgical, Absorbable, Plastic And Reconstructive SurgeryOXF1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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