Hysteroscope recalled due to missed required leakage test
Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported injuries or illnesses. However, it is a risk-of-harm product because the failed quality control test means a surgical instrument may not function properly, creating potential for harm even without currently reported incidents.
Plain-English summary
The OES 4000 Hysteroscope, Model A4674A, manufactured by Olympus Corporation of the Americas, is being recalled. Following rework to address a non-conformity, the required leakage test was not performed to verify the repair.
Without completing the required leakage test, the device has not been verified to prevent liquid ingress. Liquid could enter the eyepiece and cause a foggy image.
Anyone in possession of this device should contact Olympus Corporation of the Americas for recall instructions and guidance on device replacement or repair.
The recalled product
- Product
- OES 4000 Hysteroscope, Model/Catalog Number: A4674A
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: A4674A
- UDI-DI: 04042761006361
- Serial Number: 805904
Distribution
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