Karl Storz Biopsy and Grasping Forceps Recalled Due to Sterility Validation Failure
Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device; sterility validation failure on invasive surgical instruments poses risk of contamination and infection. No illnesses, injuries, or deaths have been reported. Per rubric, Class II without hospitalization reports and theoretical hazard rates at most High (3).
Plain-English summary
Karl Storz Endoscopy is recalling optical biopsy and grasping forceps (model REF 723400) due to a failure in manual cleaning validation that compromises sterility assurance. The recall affects 285 units distributed across 31 US states.
These forceps are invasive surgical instruments used in medical procedures. The failure of cleaning validation means the instruments may not meet required sterility standards, creating a potential risk of contamination during use.
Affected healthcare facilities should stop using this product immediately and contact Karl Storz Endoscopy for replacement or proper handling instructions. The recall is overseen by the U.S. Food and Drug Administration as a Class II device recall.
The recalled product
- Product
- Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device
- Affected units
- 285
Distribution
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