FDAClass IIJanuary 22, 2025

Karl Storz - Endoskope recall: Sterility Concern

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

Why was Karl Storz - Endoskope recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Recalling firm
Karl Storz Endoscopy
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
Recall date
January 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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