Lower riskMedical device recall · FDA · Published October 21, 2024
Karl Storz Endoscopy Irrigation Tubing Recall: FDA Labeling Issue
Karl Storz recalls irrigation tubing for Endomat Select UP210 models due to improper FDA labeling. This affects specific product numbers sold in the U.S. No immediate action needed as the hazard is labeling-related.
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.
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Contact the company
📍Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017
✎ GovInfoNow plain-language explainer
Karl Storz is recalling irrigation tubing for their Endomat Select UP210 models because the product labels were not properly reviewed and approved by the FDA for U.S. distribution. This labeling issue means the tubing may not be legally used in the U.S. as intended, but it does not pose a direct safety risk to users. Read more at govinfonow.com/recall/53668-karl-storz-endoscopy-irrigation-tubing-recall-fda-labeling-issue.
“Karl Storz Endoscopy Irrigation Tubing Recall: FDA Labeling Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53668-karl-storz-endoscopy-irrigation-tubing-recall-fda-labeling-issue. Based on FDA recall #Z-0363-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2025%22&limit=1).
Karl Storz Endoscopy recalled Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC due to improper labeling of products. The Food and Drug Administration announced the Class II recall on Oct. 21, 2024.
How to tell if you have it
Brand: Karl Storz
Product/Material Number: 031523-10
UDI-DI code: 04048438006306
Lot Number: 240222
The hazard
The hazard is due to improper labeling of products, where an intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Context
GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since Oct. 10, 2017. Other recent recalls of similar products include Karl Storz HOPKINS Telescope Recall (Aug. 12, 2026), Karl Storz Flexible Hystero-Fiberscope Kits (May 21, 2026), and Karl Storz Endoscopy Optical Biopsy Forceps Recall (Dec. 19, 2024).
How to tell if you have this one
Check for the product number 031523-10 on the tubing packaging or label. The tubing is part of the Endomat Select UP210 system and was sold with UDI-DI code 04048438006306.
Brand
Karl Storz
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the product number 031523-10 on the tubing packaging or label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Connecticut, District of Columbia, Maryland, Michigan, Minnesota, New York, North Carolina, Ohio, Oklahoma, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0363-2025 (October 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0363-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.