Official recall record
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).
- 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)
- 04953170307188
- 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.
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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