The Recall Desk
ModerateFDA (Devices)·Z-0363-2025·Announced 2024-11-20

Karl Storz Irrigation Tubing Recalled for Unapproved Label Use

Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving improper labeling with an unapproved intended use. The issue is a regulatory compliance matter regarding label documentation rather than a product defect.

Plain-English summary

Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 (REF 031523-10) due to improper labeling. The product's label includes an intended use that has not been reviewed and approved by the FDA for distribution in the United States.

The recalled product was distributed nationwide to medical facilities in Colorado, Connecticut, Washington D.C., Maryland, Michigan, Minnesota, North Carolina, New York, Ohio, Oklahoma, Tennessee, Texas, and Washington. A total of 40 units were distributed. The affected lot number is 240222 (Material Number 031523-10, UDI-DI code 04048438006306).

The recalled product

Product
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Manufacturer
Karl Storz Endoscopy
Category
Medical Device — Surgical / Endoscopy
Hazard
Affected units
40

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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