Visera Hysterovideoscope Olympus HYF Type V
FDA Recall Z-2480-2023 · Posted 2023-08-29
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeHIH
Date Initiated2023-07-20
Product Quantity363 units
Reason for Recall
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Firm 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 [email protected] or Fax 866-557-1242.
Root Cause
Reprocessing Controls
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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