Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Summary
The FDA issued a Class II for Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Se by Karl Storz Endoscopy. Reason: 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..
Details
Source
Device Recall
External ID
Z-0363-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Lot/Code Info: Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222
Quantity Affected: 40 units
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.
Distribution
U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-21
Company
El Segundo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 242 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Karl Storz Endoscopy has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Karl Storz Endoscopy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Karl Storz Endoscopy have FDA actions?
Karl Storz Endoscopy has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0363-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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