Karl Storz Endoscopy: Device Recall

Recall #Z-0837-2025 · 12/19/2024

Class II: Risk

Recall Details

Recall Number: Z-0837-2025
Classification: Class II
Product Type: Device
Recalling Firm: Karl Storz Endoscopy
Status: Ongoing
Date Initiated: 12/19/2024
Location: El Segundo, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 285 units

Reason for Recall

Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

Product Description

Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

Distribution Pattern

US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None

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.