FDA Enforcement
Class II
Ongoing
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Recall: Z-0837-2025
·
Reported January 22, 2025
Enforcement
- Recall Number
- Z-0837-2025
- Event ID
- 95954
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Karl Storz Endoscopy
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2025
- Initiation Date
- December 19, 2024
- Classification Date
- January 10, 2025
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017, United States
Description
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Reason
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Code Info
Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416
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
Quantity
285 units