Karl Storz Endoscopy
Karl Storz Endoscopy appears in FDA public data with 70 recalls, 35 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1063-2025, Class II) was initiated on December 19, 2024. Its most recent 510(k) clearance was granted on January 24, 2005.
Summary
- Total Recalls
- 70
- 510(k) Clearances
- 35
- Inspections
- 4
- Compliance Actions
- 0
Known Names
karl storz, karl storz endoscopy, karl storz endoscopy-america
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1063-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123 | December 19, 2024 |
| Z-1052-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE | December 19, 2024 |
| Z-1060-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123 | December 19, 2024 |
| Z-1056-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 01 | December 19, 2024 |
| Z-1064-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123 | December 19, 2024 |
| Z-1055-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123 | December 19, 2024 |
| Z-1053-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE | December 19, 2024 |
| Z-1057-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0 | December 19, 2024 |
| Z-1051-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123 | December 19, 2024 |
| Z-1059-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE | December 19, 2024 |
| Z-1054-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 | December 19, 2024 |
| Z-1061-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123 | December 19, 2024 |
| Z-1058-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 01 | December 19, 2024 |
| Z-0837-2025 | Class II | Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE | December 19, 2024 |
| Z-1062-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123 | December 19, 2024 |
| Z-0363-2025 | Class II | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC | October 21, 2024 |
| Z-0526-2025 | Class II | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Res | October 11, 2024 |
| Z-3223-2024 | Class II | Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 | July 23, 2024 |
| Z-3220-2024 | Class II | Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 | July 23, 2024 |
| Z-3218-2024 | Class II | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 | July 23, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | January 24, 2005 |
| K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | June 2, 2003 |
| K030009 | KSEA POWERSHAVER SYSTEM S2 | April 2, 2003 |
| K023924 | AUTOCON II 200 ELECTROSURGICAL GENERATOR | February 21, 2003 |
| K023187 | KSEA SPINOSCOPE | December 2, 2002 |
| K011700 | MODULITH SLK LITHOTRIPTER | August 16, 2002 |
| K021776 | KSEA QUADRO SWITCH | August 15, 2002 |
| K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | February 26, 2002 |
| K011841 | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR | September 10, 2001 |
| K010569 | KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP | April 9, 2001 |
| K004037 | X-RAY SYSTEM XR-MX | February 2, 2001 |
| K001630 | KSEA BIPOLAR COAGULATING ELECTRODES | July 19, 2000 |
| K992469 | KSEA SCBCOM | October 15, 1999 |
| K992027 | KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR | September 9, 1999 |
| K992541 | LAPAROCAM | August 19, 1999 |
| K992114 | KSEA CALCUSPLIT | August 18, 1999 |
| K991171 | DCI ENDOSCOPE | June 23, 1999 |
| K991228 | DCI ENDOSCOPE | June 23, 1999 |
| K990411 | MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE | May 11, 1999 |
| K983142 | KSEA C-MOUNT ARTHROSCOPES | December 7, 1998 |