Ultrasonic Bronchoscopes Recalled Due to Inadequate Drying Validation
Aizu Olympus is recalling 823 ultrasonic bronchoscopes (models BF-UC180F, BF-UC190F) because the channel air drying process was not validated, and some repaired units retained water that could cause contamination and infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: This is an FDA Class II recall for a medical device that enters the body (endoscope) with a potential contamination and infection hazard. No illnesses or injuries have been reported, and the hazard remains theoretical. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' meriting a High (3) severity rating.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 823 ultrasonic bronchoscopes (model numbers BF-UC180F and BF-UC190F) distributed nationwide in the United States. These devices are used for endoscopic procedures including real-time ultrasonic imaging and ultrasound-guided needle aspiration within the airways, tracheobronchial tree, esophagus, and surrounding organs.
The channel air drying process for these bronchoscopes was not adequately validated. Following this deficiency, some units returned to customers after repair were found to have water remaining in their channels.
Water retention in the device channels presents a potential for microbial contamination that could lead to patient infection. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 823
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 (2)
- Model Number (UDI-DI): BF-UC180F (04953170356360)
- BF-UC190F (04953170399831).
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.
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