Pentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions
Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II endoscope recall related to updated sterilization and reprocessing instructions. While no illnesses or injuries have been reported in the source text, the potential for infection from improper device reprocessing represents a risk-of-harm scenario.
Plain-English summary
Pentax of America Inc has issued an updated Reprocessing Instruction for Use (rIFU) for gastroscope and colonoscope models, including EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10, EG-2990i, EG-2990K, EG-3490K, EG29-i10, and EG-3890TK. Approximately 28,849 units of these devices were distributed nationwide between April 2014 and May 2021.
The manufacturer has issued updated reprocessing instructions to ensure proper sterilization and cleaning of these medical devices. Healthcare facilities and endoscopy centers using these devices should obtain and implement the updated Instruction for Use (rIFU) provided by Pentax of America Inc. The updated instructions should be followed for all future use and sterilization of the affected gastroscope and colonoscope models.
The recalled product
- Product
- Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Ins
- Manufacturer
- Pentax of America Inc
- Hazard
- improper-sterilization
- infection-risk
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 (1)
- All devices distributed by Pentax in the US between April 2014 and May 2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27