Bronchoscopes Recalled Due to Inadequate Air Drying Process
Aizu Olympus recalls bronchoscopes due to unvalidated air drying process. Some returned units after repair contain water in channels, creating infection risk.
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 risk-of-harm medical device recall with no reported illnesses or injuries. The hazard—water contamination in invasive airway instruments—creates a realistic infection risk, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Aizu Olympus Co., Ltd. is recalling bronchoscopes used for endoscopy and endoscopic surgery within the airways. The recall affects 1,123 units with worldwide and US nationwide distribution across multiple model numbers.
The air drying process used after repair was not validated. A small percentage of bronchoscopes returned to customers after repair contained water remaining in the channels. Water remaining in the instrument channels has the potential for contamination that could lead to the risk of infection.
This recall addresses the deficiency in the drying process validation that allowed water to remain in equipment after repair.
The recalled product
- Product
- Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT
- 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 (18)
- Model Number (UDI-DI): BF-1T150 (04953170308185)
- BF-1T60 (04953170308161)
- BF-1TH190 (04953170335181)
- BF-1TQ170 (04953170342943)
- BF-3C160 (04953170340031)
- BF-3C40 (04953170308130)
- BF-H190 (04953170335174)
- BF-MP190F (04953170395581)
- BF-MP60 (04953170308277)
- BF-P150 (04953170308178)
- BF-P190 (04953170342110)
- BF-P60 (04953170308123)
- BF-Q170 (04953170342912)
- BF-Q190 (04953170335198)
- BF-XP190 (04953170342134)
- BF-XP60 (04953170308154)
- BF-XT160 (04953170340147)
- BF-XT190 (04953170402470).
Distribution
Distributed nationwide across the United States.
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