FDAFDA · Food and drugs·Recall number Z-2449-2021
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
Published September 22, 2021 · Recall initiated: July 14, 2021
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
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax of America Inc
- Distributor
- Nationwide
- Lot
- All devices distributed by Pentax in the US between April 2014 and May 2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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