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Pentax of America Inc FDA Recalls
7 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Pentax Medical Video Processor; Model Number: EPK-i8020c;Class IIJul 16, 2025During endoscopic procedures using a combination of the vide |
| Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral deviceClass IIJan 29, 2025During endoscopic procedures using a combination of the vide |
| PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic Class IIJan 29, 2025During endoscopic procedures using a combination of the vide |
| PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic aClass IIJan 29, 2025During endoscopic procedures using a combination of the vide |
| Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel ModelsClass IIJul 14, 2021Updated Reprocessing Instruction For Use (rIFU): Impacted PE |
| Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10Class IIJul 14, 2021Updated Reprocessing Instruction For Use (rIFU): Impacted PE |
| Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipClass IIApr 21, 2021IFU updated: The warning section of the IFU for both the OE- |