Medical device recalls Moderate risk

Karl Storz Endoscopy recalls Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Recall date
October 21, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0363-2025
FDA classification
Class II
Brand / firm
Karl Storz Endoscopy
Sold / distributed
U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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