FDA recall record · openFDA
Karl Storz Endoscopy
37 FDA recalls on record (2023–2024) — 37 device. 37 still ongoing.
0
Class I (most serious)
37
Class II
0
Class III
37
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the 14
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for saf 8
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general su 5
Inadequate reprocessing validation evidence 3
Flexible intubation endoscopes sterility assurance can not be confirmed. 1
Recalls
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE Class II 2024-02-27 KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE Class II 2024-12-19 Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only Class II 2024-02-27 Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 Class II 2024-07-23 Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 Class II 2024-07-23 LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000 Class II 2024-04-01 KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 Class II 2024-12-19 Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only Class II 2024-02-27 Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC Class II 2024-10-21 Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 Class II 2024-07-23 Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 Class II 2024-07-23 KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 Class II 2024-07-23 KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x Class II 2024-10-11 KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123 Class II 2024-12-19 Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 Class II 2024-07-23 Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 Class II 2024-07-23 KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123 Class II 2024-12-19 Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Class II 2024-12-19 Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 Class II 2024-07-23 Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Class II 2023-07-07 Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A Class II 2023-10-24 Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-d Class II 2023-10-24 Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Class II 2023-10-24 Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, Class II 2023-04-06 Injection Needle, LUER-lock,0.8mm, REF: 26175PD Class II 2023-10-24 KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A Class II 2023-04-05 Injection Needle, REF: 25207 Class II 2023-10-24
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.