Recall Z-2480-2023 ยท HIH Hysteroscope (And Accessories)
Olympus Corporation of the Americas
Visera Hysterovideoscope Olympus HYF Type V
| Date | Aug 29, 2023 (initiated Jul 20, 2023) |
| Status | Open, Classified |
| Reason | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. |
| Root cause | Reprocessing Controls |
| Action | 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. |
| Quantity | 363 units |
| 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. |
| FDA record | Open on fda.gov |