Recalls / —

—#202569

Product

Visera Hysterovideoscope Olympus HYF Type V

FDA product code

HIH — Hysteroscope (And Accessories)

Device class

Class 2

Medical specialty

Obstetrics/Gynecology

510(k) numbers

K022445, K221557

Affected lot / code info

Model HYF-V, all serial numbers

Why it was recalled

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

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.

Recalling firm

Firm

Olympus Corporation of the Americas

Address

3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

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.

Timeline

Recall initiated

2023-07-20

Posted by FDA

2023-08-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.