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.
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: 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.
- Hazard
- water-contamination
- infection-risk
- sterilization-failure
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.
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