Olympus Corporation of the Americas 2023-10-25 Health critical FDA
Health · FDA · Recall #FDA-Z-0075-2024
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. Recall
Issued October 25, 2023 · Olympus Corporation of the Americas
In October 2023, Olympus Corporation of the Americas recalled the Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery., a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
What you should do
- 1 Stop using Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- October 25, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0075-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.