FDA Device recall Z-0837-2025
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE by Karl Storz Endoscopy, citing due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0837-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-19 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | 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 |
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.
Identifiers
| code_info | Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2025%22
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