Data / Medical devices / United States / Karl Storz Endoscopy-America, Inc.
Karl Storz Endoscopy-America, Inc.: FDA-registered device maker in El Segundo, CA, United States, 464 510(k) clearances and 1 PMA approval
Karl Storz Endoscopy-America, Inc. is registered with the FDA (registration 3010202439) in El Segundo, CA, United States. It lists 220 device types. The FDA files 464 510(k) clearances and 1 PMA approval under its listings, the newest dated October 14, 2026. 27 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010202439
- FEI number
- 3007475226
- Address
- 2151 E. Grand Avenue, El Segundo, CA, United States, 90245
- Owner or operator
- KARL STORZ SE & CO KG (8010119)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 20, 1978
- Registered through
- 2027
- Brand names listed
- 11274AB Flex Pediatric BRONCHOSCOPE, 11274AC Flex. CHOLEDOCHOSCOPE, 12G-SDI CABLE,, 26025UC HAMOU Elctrnc HYSTEROFLATOR, 2800C Shouldr/Ankle/Elbw/Hip/TMJ/SM, 300W Light Source, Non-flash, 3D Endoscope, 3D Video System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 464.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2026 | K260581 | KARL STORZ Flexible Video Neuro-Endoscope | GWG | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 25, 2026 | K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | HIH | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 24, 2026 | K254303 | KARL STORZ SUPRALOOP | KNF | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 18, 2026 | K261102 | UNIDRIVE Select System | HIH | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 1, 2026 | K260884 | UNIDRIVE Select System | GCJ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| August 26, 2026 | K254103 | HOPKINS Telescopes for Arthroscopy | HRX | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| August 19, 2026 | K260209 | ENDOFLATOR+; Smart Smoke Evacuation | HIF | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| July 16, 2026 | K261706 | Endomat Select (UP220) | HIG | Substantially Equivalent | KARL STORZ SE & CO. KG | accessdata.fda.gov |
| June 3, 2026 | K252800 | KARL STORZ Endoscopic Accessories for Urology | OCZ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| May 15, 2026 | K252624 | KARL STORZ Laryngoscopes and Accessories | EQN | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 11, 2026 | K254228 | KARL STORZ Trocars with Valve Seals | GCJ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| March 2, 2026 | K260003 | KARL STORZ Mediastinoscopes and Instruments | EWY | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| February 26, 2026 | K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | OWN | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| February 12, 2026 | K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | OWN | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| December 5, 2025 | K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | EOQ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| November 22, 2025 | K250927 | KARL STORZ Cholangiography Set | GCJ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| November 18, 2025 | K253411 | Miniature Telescope for Urology (27033AA) | FGB | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 22, 2025 | K250388 | ENDOFLATOR + | HIF | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| August 13, 2025 | K243653 | KARL STORZ HOPKINS Telescopes for Urology | FAJ | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| June 6, 2025 | K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | FGB | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| May 2, 2025 | K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | FBO | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| November 27, 2024 | K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | FBO | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| October 22, 2024 | K240506 | KARL STORZ Holders | OCV | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| August 1, 2024 | K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) | FGB | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| July 25, 2024 | K233372 | KARL STORZ Fiber Telescopes for Urology | FGB | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| June 10, 2024 | K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | FGB | Substantially Equivalent | Karl Storz Endovision, Inc. | accessdata.fda.gov |
| May 7, 2024 | K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | FJL | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| May 1, 2024 | K232370 | Percutaneous Nephroscope System | FGA | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| November 21, 2023 | K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | OWN | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| November 6, 2023 | K232857 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| October 3, 2023 | K232406 | KARL STORZ OR1 SCB CONTROL (WU300) | ODA | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 14, 2023 | K223885 | HOPKINS Telescopes | HIH | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| September 8, 2023 | K230535 | KARL STORZ Urological Laser Accessories | GEX | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| June 23, 2023 | K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | GCJ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| April 27, 2023 | K223520 | UNIDRIVE SIII System | HIH | Substantially Equivalent | Karl Storz-Endoscopy-America, Inc. | accessdata.fda.gov |
| March 30, 2023 | K223923 | HOPKINS Telescopes | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 17, 2023 | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | FJL | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| December 20, 2022 | K221004 | HOPKINS Telescopes | GCJ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| November 10, 2022 | K222504 | H1 | GCJ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| June 23, 2022 | K213194 | HD Mediastinoscope | EWY | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| May 13, 2022 | K221174 | Telepack + | FET | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| January 20, 2022 | K212458 | Flexible Video-Uretero-Renoscope SSU System | FGB | Substantially Equivalent | Karl Storz Endoscopy America | accessdata.fda.gov |
| December 29, 2021 | K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | EOQ | Substantially Equivalent | Karl Storz Endoscopy America | accessdata.fda.gov |
| November 15, 2021 | K212695 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | Karl Storz Endoscopy America | accessdata.fda.gov |
| September 3, 2021 | K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | FAJ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| July 6, 2021 | K203198 | KARL STORZ Metal Sterilization Trays | KCT | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| May 7, 2021 | K203572 | Karl Storz Radel Sterilization Trays | KCT | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| February 25, 2021 | K201945 | KARL STORZ UDEL Sterilization Trays | KCT | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| December 17, 2020 | K202925 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | Karl Storz Endoscopy_America, Inc. | accessdata.fda.gov |
| November 20, 2020 | K201526 | TIPCAM1 Rubina Video Endoscope System | GCJ | Substantially Equivalent | Karl Storz Endoscopy America | accessdata.fda.gov |
| October 29, 2020 | K202957 | Flexible Video Cysto-Urethroscope (C-view) | FAJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 22, 2020 | K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | ERL | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 1, 2020 | K201135 | Image1 S CCU, Image1 S 4U Camera Head | FET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 17, 2020 | K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | OWN | Substantially Equivalent | Karl Storz-Endoscopy-America, Inc. | accessdata.fda.gov |
| August 11, 2020 | K200740 | HD Video Rhino Laryngoscope | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| July 22, 2020 | K201355 | Endomat Select, IBS Shaver Software, License | HIG | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| June 23, 2020 | K201096 | CO2mbiLED | FCX | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| January 27, 2020 | K192090 | CMOS Video Rhino-Laryngoscope SSU | EOB | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| January 24, 2020 | K192523 | CMOS Video Esophagoscope SSU | EOX | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| September 18, 2019 | K191357 | Flexible HD Cysto-Urethroscope System | FAJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| April 23, 2019 | K182723 | Flexible HD Cysto-Urethroscope System | FAJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 22, 2019 | K182186 | CMOS Video-Rhino-Laryngoscope System | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 18, 2019 | K183264 | Flex-THOR scope | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 20, 2018 | K182696 | Telepack X LED | FET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 31, 2018 | K180735 | Endomat Select | HIG | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| July 18, 2018 | K180977 | KARL STORZ New Generation Trocars | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| April 17, 2018 | K180146 | KARL STORZ ICG Imaging System | GWG | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| February 2, 2018 | K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 2, 2017 | K171717 | AUTOCON III 400 | GEI | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| July 7, 2017 | K162992 | Karl Storz UROMAT E.A.S.I. | LJH | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| May 25, 2017 | K171238 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 16, 2017 | K170462 | KARL STORZ ShuntScope | GWG | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 16, 2017 | K162880 | TIPCAM 1S 3D System | GWG | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| March 2, 2017 | K162410 | TIPCAM 1S 3D System | EOB | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| March 2, 2017 | K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | HIF | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 26, 2017 | K162882 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 21, 2016 | K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | PGW | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| September 17, 2016 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | GWG | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 31, 2016 | K152583 | KARL STORZ Endoscopic ICG Imaging System | OWN | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| February 1, 2016 | K160044 | Image1 SPIES System | FET | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| January 8, 2016 | K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces | ERL | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| November 20, 2015 | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | HET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 9, 2015 | K151044 | CLICKLINE Scissor Insert for Single Use | GEI | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| September 17, 2015 | K143640 | KSEA CMOS Camera System (C-cam) | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 23, 2014 | K142556 | Flexible Video-Uretero-Choledochoscope System | FGB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 4, 2014 | K140964 | CALCULASE II | GEX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 11, 2014 | K141250 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | FGB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 2, 2014 | K131364 | FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE | FBO | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 20, 2013 | K131953 | IMAGE1 SPIES | FET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 26, 2013 | K131369 | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | FGB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 26, 2013 | K122983 | KSEA BIPOLAR ELECTRODE | HIN | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 25, 2013 | K123956 | POWER LED 175 | FCW | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 27, 2012 | K122096 | KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM | HAW | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 28, 2012 | K103467 | CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| April 6, 2012 | K111997 | IMAGE1 GI CCU MODEL 22203020-114 | FET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 6, 2012 | K111165 | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE | ODA | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 13, 2011 | K112480 | VIEW 1 IMAGING | LLZ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| August 29, 2011 | K103308 | AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE | LLZ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 15, 2010 | K093054 | SCALP DURA RETRACTOR, MODEL KS00474 | GZT | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 18, 2010 | K093471 | KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 28, 2010 | P050027 | KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM | OAY | 35 | October 14, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | 99586 | Class II | Ongoing | HOPKINS Telescope 30, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS and HOPKINS II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures | Due to incorrect inside packaging label for eyepiece. | accessdata.fda.gov |
| May 21, 2026 | 99027 | Class II | Ongoing | Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. | 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. | accessdata.fda.gov |
| December 19, 2024 | 95975 | Class II | Ongoing | KARL 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. | accessdata.fda.gov |
| December 19, 2024 | 95954 | Class II | Ongoing | Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. | accessdata.fda.gov |
| October 21, 2024 | 95607 | Class II | Ongoing | Irrigation 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. | accessdata.fda.gov |
| October 11, 2024 | 95566 | Class II | Ongoing | 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 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. | accessdata.fda.gov |
| July 23, 2024 | 95220 | Class II | Ongoing | Karl 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. | accessdata.fda.gov |
| April 1, 2024 | 94389 | Class II | Ongoing | LASER 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. | accessdata.fda.gov |
| February 27, 2024 | 94171 | Class II | Ongoing | Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only | Inadequate reprocessing validation evidence | accessdata.fda.gov |
| October 24, 2023 | 93328 | Class II | Ongoing | Injection Needle, REF: 25207 | 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. | accessdata.fda.gov |
| July 7, 2023 | 92796 | Class II | Ongoing | Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only | Flexible intubation endoscopes sterility assurance can not be confirmed. | accessdata.fda.gov |
| April 6, 2023 | 92244 | Class II | Ongoing | 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, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 395 | 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 information regarding the sterilization modality. | accessdata.fda.gov |
| April 5, 2023 | 92182 | Class II | Ongoing | KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A | 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 information regarding the sterilization modality. | accessdata.fda.gov |
| May 3, 2022 | 90025 | Class II | Ongoing | STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VI | The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue. | accessdata.fda.gov |
| April 1, 2022 | 89881 | Class II | Ongoing | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | accessdata.fda.gov |
| April 1, 2022 | 89880 | Class II | Ongoing | CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1 | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | accessdata.fda.gov |
| October 15, 2021 | 88998 | Class II | Ongoing | Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CA | To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality. | accessdata.fda.gov |
| September 10, 2021 | 88694 | Class II | Ongoing | FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units) | During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection. | accessdata.fda.gov |
| July 27, 2020 | 86009 | Class II | Ongoing | Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endo | Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in | accessdata.fda.gov |
| December 6, 2019 | 85089 | Class II | Terminated | Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 840 | The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body. | accessdata.fda.gov |
| August 27, 2019 | 84896 | Class II | Ongoing | Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted sco | accessdata.fda.gov |
| April 24, 2019 | 83419 | Class II | Terminated | Flexible Intubation Fiberscope, Model # 11301AB1 | The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer. | accessdata.fda.gov |
| February 20, 2019 | 83459 | Class II | Terminated | FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. | accessdata.fda.gov |
| January 9, 2019 | 85388 | Class III | Terminated | Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10 | The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. | accessdata.fda.gov |
| October 10, 2017 | 78289 | Class II | Terminated | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches | The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product. | accessdata.fda.gov |
| June 20, 2016 | 74515 | Class II | Terminated | Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG). | accessdata.fda.gov |
| June 25, 2014 | 68646 | Class II | Terminated | Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit. | KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to. | accessdata.fda.gov |
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Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.