FDAFDA · Food and drugs·Recall number Z-1275-2022
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Published June 29, 2022 · Recall initiated: April 22, 2022
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
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- US Nationwide distribution in the states of AL, FL, NC, NY.
- Lot
- UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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