Visera Hysterovideoscope Olympus HYF Type V recallZ-2480-2023 · Olympus Corporation of the Americas · initiated Jul 20, 2023
Class II Open, Classified All recalls posted in August 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
FDA root cause category: Reprocessing Controls
What the company is doing
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.
Recall details
- Recall number
- Z-2480-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 20, 2023
- Posted by the FDA
- Aug 29, 2023
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 363 units
- Product code
- HIH
- FDA submissions
- K221557, K022445
- 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 description
Visera Hysterovideoscope Olympus HYF Type V
Code information (models, lots, serial numbers)
Model HYF-V, all serial numbers
Other devices under the same FDA submission
3 devices cleared under K221557, K022445 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VOlympus Medical Systems Corp. · HYSTEROSCOPE (AND ACCESSORIES)1 recall48 reports
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VOlympus Medical Systems Corp. · HYSTEROSCOPE (AND ACCESSORIES)15 reports
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VOlympus Medical Systems Corp. · Hysteroscope (And Accessories)12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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