CLASS II ONGOING Device recall · Reported 22 Jun 2022 · FDA Enforcement Report

Olympus Cystonephrofiberscope recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus Cystonephrofiberscope, distributed in 8 states. The recall was initiated on 20 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060

Quantity recalled7 units

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-1262-2022
FDA event ID: 90195
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Apr 2022
FDA classified: 13 Jun 2022
Reported: 22 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Apr 2022	Recall initiated by company
13 Jun 2022	Classified by FDA	+54 days
22 Jun 2022	Published in enforcement report	+9 days

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

Reason for recall

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

Product as listed by the FDA

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

Where it was distributed

CA FL MA MD MI NJ OH PR WI

California Florida Massachusetts Maryland Michigan New Jersey Puerto Rico Wisconsin

Questions about this recall

Is Olympus Cystonephrofiberscope recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Cystonephrofiberscope on 20 Apr 2022. The recall is Class II and its status is Ongoing. Recall number Z-1262-2022.

Why was it recalled?

Which lots are affected?

UDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060

Where was it sold?

CA FL MA MD MI NJ OH PR WI

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 21 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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