Karl Storz Endoscopy

Complete recall history across all FDA and CPSC categories — 70 total recalls

Karl Storz Endoscopy appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (70)

FDA medical device enforcement actions by Karl Storz Endoscopy. Showing most recent 50.

Date Product Reason Class
Dec 19, 2024 Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Due to failure of manual cleaning validation, biopsy and grasping forceps lik... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON ... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE,... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123 Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, N... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STER... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON ... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NO... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERI... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm,... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STER... Scope IFUs contain a reprocessing modalities that have not been reviewed and/... Class II
Oct 21, 2024 Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... Due to improper labeling of products. An intended use on the label has not be... Class II
Oct 11, 2024 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2... Due to holes detected in the inner barrier system that may compromise the ste... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, C... Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, C... Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that hav... Class II
Jul 23, 2024 Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that hav... Class II
Apr 1, 2024 LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... Laser surgical instruments have no specific evidence of a validated reprocess... Class II
Feb 27, 2024 Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only Inadequate reprocessing validation evidence Class II
Feb 27, 2024 Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only,... Inadequate reprocessing validation evidence Class II
Feb 27, 2024 Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE Inadequate reprocessing validation evidence Class II
Oct 24, 2023 Injection Needle, REF: 25207 The efficacy of the manual cleaning process cannot be assured for the affecte... Class II
Oct 24, 2023 Injection Needle, LUER-lock,0.8mm, REF: 26175PD The efficacy of the manual cleaning process cannot be assured for the affecte... Class II
Oct 24, 2023 Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, sing... The efficacy of the manual cleaning process cannot be assured for the affecte... Class II
Oct 24, 2023 Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm... The efficacy of the manual cleaning process cannot be assured for the affecte... Class II
Oct 24, 2023 Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A The efficacy of the manual cleaning process cannot be assured for the affecte... Class II
Jul 7, 2023 Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Flexible intubation endoscopes sterility assurance can not be confirmed. Class II
Apr 6, 2023 Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R... Metal sterilization trays used to encase and protect medical devices during s... Class II
Apr 5, 2023 KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... Plastic sterilization trays used to encase and protect medical devices during... Class II
May 3, 2022 STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF... The endoscope may experience a loss of image when activating monopolar electr... Class II
Apr 1, 2022 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VA... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 ... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/20... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF ... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A F... Failure to achieve the expected six-log reduction in microorganisms following... Class II
Apr 1, 2022 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) Failure to achieve the expected six-log reduction in microorganisms following... Class II

View all 70 device recalls →

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