Z-2480-2023 Class II Ongoing
FDA device recall Z-2480-2023 was initiated by Olympus Corporation of the Americas on July 20, 2023 and is designated Class II. Reason for recall: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. The recall status is ongoing. Affected quantity: 363 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 363 units
Product Description
Visera Hysterovideoscope Olympus HYF Type V
Reason for Recall
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Distribution Pattern
US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.
Code Information
Model HYF-V, all serial numbers