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.
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 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.
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 · contamination
See all →- HighMedline Recalls Cataract Preop Kits with Potentially Contaminated Applicators
FDA (Devices) · 2026-09-09
- HighFresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
FDA (Devices) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to Contamination
FDA (Drugs) · 2026-09-09
- HighMedline Ortho Aspiration Kits Recalled for Potential Contamination
FDA (Devices) · 2026-09-09