FDA recall Z-2249-2025
AVID Medical, Inc. · Class II · device
Product
GS ENDOSCOPY PACK. Medical convenience kit.
Reason for recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Distribution
Domestic: CA, IL, MD, OH, PA, TX, WA.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-06-11
- Report date
- 2025-08-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2249-2025