Visera Hysterovideoscope Olympus HYF Type V
This recall is currently active, issued August 29, 2023. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- July 20, 2023
- Posted
- August 29, 2023
- Recall Number
- Z-2480-2023
- Quantity
- 363 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Distribution
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.
Lot / Code Info
Model HYF-V, all serial numbers
Root Cause
Reprocessing Controls
Action Taken
A customer letter was issued on July 20, 2023. Customers were advised that the Instructions for use were updated. Customers are asked to complete a response form of acknowledgement and submit to Sedgwick at olympus8606@sedgwick.com or Fax 866-557-1242.