CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Irrigation Tubing for Karl Storz Endomat Select UP210 recalled

Karl Storz Endoscopy is recalling Irrigation Tubing for Karl Storz Endomat Select UP210, distributed nationwide in the US. The recall was initiated on 21 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

Quantity recalled40 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-0363-2025
FDA event ID: 95607
Recalling firm: Karl Storz Endoscopy, El Segundo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Oct 2024
FDA classified: 12 Nov 2024
Reported: 20 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Oct 2024	Recall initiated by company
12 Nov 2024	Classified by FDA	+22 days
20 Nov 2024	Published in enforcement report	+8 days

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

Reason for recall

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

Product as listed by the FDA

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Where it was distributed

U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

Nationwide Colorado Connecticut District of Columbia Maryland Michigan Minnesota North Carolina New York Ohio Oklahoma Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

Which lots are affected?

Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

Where was it sold?

U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

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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5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
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