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.
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 3/5 (High).
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…
- Manufacturer
- Pentax of America Inc
- Affected units
- 28,849
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.
Part of a larger recall action
This product is one of 2 recalled by Pentax of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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