Bioenterics Corporation
FDA adverse event reports naming Bioenterics Corporation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOENTERICS CORPORATION.
- Total reports
- 1,857
- Deaths
- 29
- Injuries
- 302
- Malfunctions
- 1,509
Reports per year
198
300
2001
30902
28203
29604
34005
24406
14507
17408
4209
114
Source: FDA adverse event reports by year received, 1998–2014. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implant, Intragastric For Morbid ObesityLTI1,822
- Catheter, Angioplasty, Peripheral, TransluminalLIT18
- Image, Illumination, Fiberoptic, For Endoscope FFS4
- Implant, Anti-Gastroesophageal RefluxLEI4
- Retractor, FiberopticFDG3
- Resin, Denture, Relining, Repairing, RebasingEBI1
- Illuminator, Fiberoptic, Surgical FieldHBI1
- Bougie, Esophageal, EntKCD1
- Tubes, Gastrointestinal (And Accessories)KNT1
- Panels, Test, Susceptibility, AntimicrobialLTT1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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