Unknown
FDA adverse event reports naming Unknown as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: UNKNOWN.
- Total reports
- 16,438
- Deaths
- 168
- Injuries
- 5,340
- Malfunctions
- 7,695
Reports per year
85912
2,32813
2,78914
1,41215
44416
8117
4218
21019
16120
16621
32022
2,53823
49824
59525
47626
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Walker, MechanicalITJ1,978
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR1,733
- Wheelchair, PoweredITI1,230
- Wheelchair, MechanicalIOR1,223
- Aid, TransferIKX741
- Lift, Patient, Non-Ac-PoweredFSA708
- Adaptor, HygieneILS666
- Catheter, Peritoneal, Long-Term IndwellingFJS623
- Catheter, Peripheral, AtherectomyMCW532
- Bed, Ac-Powered Adjustable HospitalFNL442
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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