Official recall record
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-10-16
- Country of alert
- Japan
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04953170305191
- Brand on record
- Aizu Olympus Co., Ltd.
What the authority reported
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-10-16 · US FDA — Medical Devices
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-16 · US FDA — Medical Devices
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE - 2023-09-25 · US FDA — Medical Devices
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, col
All 18 official recall notices naming Aizu Olympus Co., Ltd. on this site →
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