Olympus EVIS EXERA III Colonoscope Recall for Connector Defect
24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.
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 an FDA Class II recall for a medical device used in patient procedures. The defect poses risk of serious patient harm through potential infection due to contamination exposure, but no illnesses or injuries have been reported in the source material, keeping the score at 'High' rather than 'Severe.'
Plain-English summary
The FDA is recalling 24 units of the Olympus EVIS EXERA III Colonovideoscope (model PCF-H190L) due to a manufacturing defect. These devices were distributed to medical facilities in Florida, Kentucky, Massachusetts, New Jersey, New York, and Pennsylvania. Specifically, units with serial numbers 2302719 and 2516751 are affected.
The problem is an improperly repaired light guide connector where adhesive is missing from the suction channel mouthpiece connection point. This defect can prevent the colonoscope from displaying images properly, reduce suction power, or prevent the device from being properly cleaned and disinfected for reuse. Any of these failures could delay patient treatment or result in patients being exposed to contaminated equipment, potentially leading to infection.
The recalled product
- Product
- PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 24
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 (2)
- UDI-DI 04953170305191 Serial Numbers 2302719
- 2516751
Distribution
Part of a larger recall action
This product is one of 5 recalled by Aizu Olympus Co., Ltd. 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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