Pentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions
Pentax of America Inc is recalling video gastroscopes to provide customers with the most recent Operation and Reprocessing Instructions (IFUs).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action to provide updated documentation (IFUs) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pentax of America Inc is initiating a field action for the Pentax Video Gastroscope. The recall is intended to provide customers who have purchased the affected endoscopes with the most recent Operation and Reprocessing Instructions (IFUs).
The affected devices are intended to be used with a Pentax video processor, documentation equipment, monitor, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract, including the esophagus, stomach, and duodenum. The recall covers 3,436 units in the United States and 14,488 units outside the United States. Distribution was nationwide in the US and in Japan.
Customers who have purchased the affected endoscopes should contact Pentax of America Inc to obtain the updated Operation and Reprocessing Instructions. The specific model codes affected include EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-349oK, and EG-3890TK.
The recalled product
- Product
- Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- EG-1690K
- EG-2490K
- EG-279oI
- EG-2790K
- EG-2990K
- EG-349oK and EG-3890TK
Distribution
Distributed nationwide across the United States.
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