FDAFDA · Food and drugs·Recall number Z-0333-2024
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Published November 29, 2023 · Recall initiated: September 25, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aizu Olympus Co., Ltd.
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- Model Numbers: GF-UC140P-AL5 (04953170356322), GF-UCT180 (04953170356339), GF-UE160-AL5 (04953170356261).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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