FDA recall Z-0837-2025

Karl Storz Endoscopy · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-12-19
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0837-2025