Z-0837-2025 Class II Ongoing

Recalled by Karl Storz Endoscopy — El Segundo, CA

Recall Details

Product Type
Devices
Report Date
January 22, 2025
Initiation Date
December 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
285 units

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.

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

Code Information

Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416