Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial Recalled by Aizu Olympus Co., Ltd. Due to Channel air drying process was not validated, and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aizu Olympus Co., Ltd. directly.
Affected Products
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-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
Quantity: 1123 units
Why Was This Recalled?
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aizu Olympus Co., Ltd.
Aizu Olympus Co., Ltd. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report