CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report

Colonoscope, Model Number CF-Q180AL recalled

Olympus Corporation of the Americas is recalling Colonoscope, Model Number CF-Q180AL, distributed nationwide in the US. The recall was initiated on 11 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: CF-Q180AL; UDI DI: 04953170307706; Serial Number: 2602060, 2603763;

Quantity recalled2

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-1208-2024
FDA event ID: 93832
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jan 2024
FDA classified: 29 Feb 2024
Reported: 6 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

11 Jan 2024	Recall initiated by company
29 Feb 2024	Classified by FDA	+49 days
6 Mar 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

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Colonoscope, Model Number CF-Q180AL.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Colonoscope, Model Number CF-Q180AL recalled?

Yes. Olympus Corporation of the Americas recalled Colonoscope, Model Number CF-Q180AL on 11 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1208-2024.

Why was it recalled?

Which lots are affected?

Model Number: CF-Q180AL; UDI DI: 04953170307706; Serial Number: 2602060, 2603763;

Where was it sold?

US Nationwide distribution.

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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