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Recall Observatory FDA recall evidence

Device product

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

Z-0837-2025

December 19, 2024

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 95954
Status
Ongoing
Classification
Class II
Quantity
285 units
Official record key
device-enforcement:Z-0837-2025

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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