Reported Jun 12, 2024 · Ongoing
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- OES 4000 Hysteroscope
- Model/Catalog NumberA4674A
- Lot codes and dates
- Model/Catalog NumberA4674A
- UDI-DI04042761006361
- Serial Number805904
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- NY
Why it was recalled
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
This product could cause temporary or reversible health problems — stop using it.
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