CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report

OES 4000 Hysteroscope recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling OES 4000 Hysteroscope, distributed nationwide in the US. The recall was initiated on 18 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2029-2024
FDA event ID: 94638
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Apr 2024
FDA classified: 6 Jun 2024
Reported: 12 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

18 Apr 2024	Recall initiated by company
6 Jun 2024	Classified by FDA	+49 days
12 Jun 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Where it was distributed

US Nationwide distribution in the state of NY.

Nationwide New York

Questions about this recall

Why was it 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.

Which lots are affected?

Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Where was it sold?

US Nationwide distribution in the state of NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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