Z-2480-2023Class II

Visera Hysterovideoscope Olympus HYF Type V

Name: Z-2480-2023 Visera Hysterovideoscope Olympus HYF Type V
Creator: Olympus Corporation of the Americas
Published: 2023-07-20
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-07-20 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Visera Hysterovideoscope Olympus HYF Type V on 2023-07-20. FDA classified it as Class II and gives the reason as "IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2480-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-20
Posted: 2023-08-29
Recalling firm: OLYMPUS Corporation of the Americas
Product: Visera Hysterovideoscope Olympus HYF Type V
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Root cause tag: labeling and UDI
FDA 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 [email protected] or Fax 866-557-1242.
Quantity in commerce: 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.
Product codes and lots: Model HYF-V, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2480-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2480-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-29

Product code HIH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)