Karl Storz Endoscopy recalls
Karl Storz Endoscopy appears in 72 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 72 |
|---|---|
| Published | 2014-07-16 to 2026-10-07 |
| By agency | FDA Device (72) |
| By classification | Class II (71), Class III (1) |
| By status | ongoing (65), terminated (7) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visual…
FDA Device · Class II · 2026-10-07 · Karl Storz Endoscopy
Reason: Due to incorrect inside packaging label for eyepiece. - Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1
FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy
Reason: Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility. - 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
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - 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
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
FDA Device · Class II · 2025-01-22 · Karl Storz Endoscopy
Reason: Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. - 4.5 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 28205N…
FDA Device · Class II · 2024-12-04 · Karl Storz Endoscopy
Reason: Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. - Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
FDA Device · Class II · 2024-11-20 · Karl Storz Endoscopy
Reason: 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. - Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. - LASER Application Instrument, 23 cm, REF: 8694
FDA Device · Class II · 2024-05-22 · Karl Storz Endoscopy
Reason: 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 ar… - Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
FDA Device · Class II · 2024-04-10 · Karl Storz Endoscopy
Reason: Inadequate reprocessing validation evidence - Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
FDA Device · Class II · 2024-04-10 · Karl Storz Endoscopy
Reason: Inadequate reprocessing validation evidence - Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
FDA Device · Class II · 2024-04-10 · Karl Storz Endoscopy
Reason: Inadequate reprocessing validation evidence - Injection Needle, REF: 25207
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy
Reason: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. - Injection Needle, LUER-lock,0.8mm, REF: 26175PD
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy
Reason: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. - Injection Needle, 3 Fr., REF: 27030N
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy
Reason: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. - Injection Needle, single cvd. 70 degrees, REF: 738750
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy
Reason: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. - Injection Needle, curved 23 cm, REF: 8598A
FDA Device · Class II · 2023-12-27 · Karl Storz Endoscopy
Reason: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. - Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
FDA Device · Class II · 2023-09-27 · Karl Storz Endoscopy
Reason: Flexible intubation endoscopes sterility assurance can not be confirmed. - KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
FDA Device · Class II · 2023-06-28 · Karl Storz Endoscopy
Reason: Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes informat… - Metal Tray, 178 x 135 x 37 mm, REF: 11580A
FDA Device · Class II · 2023-06-28 · Karl Storz Endoscopy
Reason: Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes informatio… - STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R…
FDA Device · Class II · 2022-06-15 · Karl Storz Endoscopy
Reason: The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue. - 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272…
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Uret…
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.