Karl Storz Endoscopy
29 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Karl Storz Endoscopy and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-02-05FDA-DeviceClass IIKARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-01-22FDA-DeviceClass IIKarl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
- 2024-12-04FDA-DeviceClass II4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
- 2024-11-20FDA-DeviceClass IIIrrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-10-02FDA-DeviceClass IIKarl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2024-05-22FDA-DeviceClass IILASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
- 2024-04-10FDA-DeviceClass IIKarl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Inadequate reprocessing validation evidence
- 2024-04-10FDA-DeviceClass IIKarl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Inadequate reprocessing validation evidence
- 2024-04-10FDA-DeviceClass IIKarl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Inadequate reprocessing validation evidence
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