FDA Medical devices recall ·
Irrigation Tubing for KARL STORZ Endomat Select UP210 recall
- Recall number
- Z-0363-2025
- Date
- (initiated October 21, 2024)
- Company / brand
- Karl Storz Endoscopy
2151 E Grand Ave, El Segundo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 40 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222
Distribution
U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
States: Colorado Connecticut District of Columbia Maryland Michigan Minnesota North Carolina New York Ohio Oklahoma Tennessee Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0363-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.