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.
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FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
All Karl Storz Endoscopy recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.