Official recall record
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numb
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-09-25
- Country of alert
- Japan
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04953170343360
- Brand on record
- Aizu Olympus Co., Ltd.
What the authority reported
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of 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.
Same barcode in other registries
The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-10-02 · US FDA — Medical Devices
EVIS EXERA III Gastrointestinal Videoscope - 2024-09-18 · US FDA — Medical Devices
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe
Other recalls from this brand
- 2023-10-16 · US FDA — Medical Devices
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE - 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
All 18 official recall notices naming Aizu Olympus Co., Ltd. on this site →
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