Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0328-2024

U.S. FDA — Device Enforcement · Japan · 2023-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0328-2024
Date of alert
2023-09-25
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
Aizu Olympus Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170356360
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.