Endoscopic surgical instruments recalled for unvalidated drying process
Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.
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: This is a Class II FDA-classified recall affecting surgical instruments used in sensitive medical procedures. The unvalidated drying process created a risk of water contamination and potential infection in instrument channels. Because no illnesses or injuries have been reported, the hazard remains theoretical, placing this at the High severity tier.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling cystonephroscope endoscopes used for diagnosis and treatment within the bladder, urethra, and kidney. Approximately 1,243 units have been distributed worldwide, including within the United States. The affected model numbers are CYF-5, CYF-VH, and CYF-VHR.
The channel air drying process was not validated by the manufacturer. As a result, a small percentage of scopes returned to customers after repair had water remaining in the instrument channels. Water remaining in the endoscope channels has the potential for contamination that could lead to the risk of infection.
Patients undergoing urological procedures with affected endoscopes may be exposed to contaminated instruments. Healthcare facilities and practitioners using these instruments should be aware of this recall and take appropriate precautions with affected units.
The recalled product
- Product
- Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Hazard
- water-contamination
- infection-risk
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): CYF-5 (04953170292323)
- CYF-VH (04953170411250)
- CYF-VHR (04953170411298).
Distribution
Distributed nationwide across the United States.
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