Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
FDA Recall #Z-0837-2025 — Class II — December 19, 2024
Product Description
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Reason for Recall
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Recalling Firm
Karl Storz Endoscopy — El Segundo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
285 units
Distribution
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
Code Information
Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated