Visera Hysterovideoscope Olympus HYF Type V recall: Labeling Error
Visera Hysterovideoscope Olympus HYF Type V
Why was Visera Hysterovideoscope Olympus HYF Type V recalled?
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model HYF-V, all serial numbers
- Product
- Visera Hysterovideoscope Olympus HYF Type V
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)