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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 40
Distribution
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