Recall archive / FDA device enforcement
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE — FDA record Z-0837-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 285 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0837-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 22, 2025
- Recall initiation date
- Dec 19, 2024
- Center classification date
- Jan 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.