FDA-Device2024-06-12Class II
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Hazard
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.
Sold states
US Nationwide distribution in the state of NY.
Affected count
1 unit
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2024More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief