Karl Storz Endoscopy: Device Recall

Recall #Z-0363-2025 · 10/21/2024

Class II: Risk

Recall Details

Recall Number: Z-0363-2025
Classification: Class II
Product Type: Device
Recalling Firm: Karl Storz Endoscopy
Status: Ongoing
Date Initiated: 10/21/2024
Location: El Segundo, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 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.

Product Description

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Distribution Pattern

U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

Other Recalls by Karl Storz Endoscopy

Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II: Risk 12/19/2024

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

View all recalls by Karl Storz Endoscopy →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.