Choleodochoscope Models Recalled Due to Unvalidated Air Drying Process
Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III classification with no reported illnesses typically results in Score 1–2. However, this qualifies as a risk-of-harm product (medical device for invasive procedures) with documented water contamination potential, meeting the Score 3 criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling three models of choleodochoscope: CHF-BP30, CHF-CB30L, and CHF-P60. Choleodochoscopes are endoscopes used for examination and treatment of the bile duct.
The air drying process used after device repair was not properly validated. A small percentage of units returned to customers after service contained water in the instrument channel. Water remaining in the channel creates potential for microbial contamination that could lead to infection during patient procedures.
The recalled devices have worldwide and US distribution. Healthcare facilities and clinical providers using these models should discontinue use and contact Aizu Olympus for instructions on inspection, replacement, or remediation.
The recalled product
- Product
- Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 3
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 (3)
- Model Number (UDI-DI): CHF-BP30 (04953170068751)
- CHF-CB30L (04953170340154)
- CHF-P60 (Not recorded).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 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.
See all 22 products in this recall →Related recalls
Same manufacturer · Aizu Olympus Co., Ltd.
See all →- LowOlympus OER-Elite devices recalled with a notice on warnings and maintenance
FDA (Devices) · 2025-12-10
- LowOlympus OER-Pro devices recalled with a notice on warnings and maintenance
FDA (Devices) · 2025-12-10
- LowOlympus OER-Mini devices recalled with a notice on warnings and maintenance
FDA (Devices) · 2025-12-10
- HighGastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk
FDA (Devices) · 2023-12-06
- HighColonoscope Repair Defect May Cause Device Malfunction and Contamination Risk
FDA (Devices) · 2023-12-06
Same hazard · water contamination
See all →- HighVFAUOSIT Kitchen Faucets Recalled for Lead Leaching Into Water
CPSC · 2025-05-29
- HighBASDEHEN Kitchen Faucets Recalled Due to Dangerous Lead Exposure
CPSC · 2025-05-29
- HighEndoscopic surgical instruments recalled for unvalidated drying process
FDA (Devices) · 2023-11-29
- HighTracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying
FDA (Devices) · 2023-11-29
- HighGastrointestinal videoscopes recalled due to unvalidated channel drying process
FDA (Devices) · 2023-11-29
Similar recalls
- SevereOlympus Choledoscope Recalled for Lack of Clearance and Breakage
FDA (Devices) · 2020-10-28
- HighOlympus Ultrasound Endoscope Recall for Updated Cleaning Instructions
FDA (Devices) · 2020-12-09
- ModerateOlympus JF-160F Duodenoscopes Recalled for New Reprocessing Procedures
FDA (Devices) · 2018-06-27
- HighOlympus Ultrasound Endoscope Recall for Infection Risk
FDA (Devices) · 2020-12-09
- HighOlympus colonoscope repair defect may impair imaging and suction function
FDA (Devices) · 2023-12-06
- HighAir/Water Valve Used with Olympus Endoscopes May Malfunction
FDA (Devices) · 2023-08-30