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Karl Storz Endoscopy

Country not established

Devices
35
FDA recalls
7254 ongoing
11 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Karl Storz Endoscopy makes

The company manufactures rigid and flexible endoscopes for neurosurgery, including neuroendoscope sets and a switch system for imaging, as well as electrosurgical generators for tissue management. It also produces plastic trocars, culdocentesis sets, and hand extractors for surgical assistance. Uterine manipulators, hysteroscopes, and flexible cholangioscopes are part of its gynecological and biliary endoscopy portfolio, alongside middle ear prostheses and arthroscopy sets for joint procedures.

These devices are classified as Class II under FDA regulations and are recorded in the 510(k) clearance database. The company operates with a US manufacturing presence.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue35

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FDA recalls72

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 72 recalls initiated by Karl Storz Endoscopy, the earliest on 2014-06-25 and the most recent on 2026-08-12. By recorded status: 65 ongoing and 7 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 7
  • 2020 8
  • 2021 2
  • 2022 13
  • 2023 8
  • 2024 29
  • 2025 0
  • 2026 2

2 initiated before 2017

Showing the 10 most recent of 72 recalls.

  • 2026

    • 12 Aug 2026 Z-3333-2026 Class II Ongoing Due to incorrect inside packaging label for eyepiece. Distribution: U.S. Nationwide distribution in the states of AZ, CA and MO. Submission number: K945788
    • 21 May 2026 Z-2794-2026 Class II Ongoing 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. Distribution: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. Submission number: K961605

  • 2024

    • 19 Dec 2024 Z-0837-2025 Class II Ongoing Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. Distribution: US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA,…
      Full distribution text US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
    • 19 Dec 2024 Z-1051-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1052-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1053-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1054-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1055-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1056-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1057-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
Show the 25 most recent of 72 recalls

  • 2024

    • 19 Dec 2024 Z-1058-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1059-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1060-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1061-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1062-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1063-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 19 Dec 2024 Z-1064-2025 Class II Ongoing Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution. Submission number: K233372
    • 21 Oct 2024 Z-0363-2025 Class II Ongoing 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. Distribution: U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
    • 11 Oct 2024 Z-0526-2025 Class II Ongoing Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and…
      Full distribution text Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.
      Submission number: K030009
    • 23 Jul 2024 Z-3218-2024 Class II Ongoing Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text US Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
      Submission number: K232370
    • 23 Jul 2024 Z-3219-2024 Class II Ongoing Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text US Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
      Submission number: K232370
    • 23 Jul 2024 Z-3220-2024 Class II Ongoing Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text US Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
      Submission number: K232370
    • 23 Jul 2024 Z-3221-2024 Class II Ongoing Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text US Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
      Submission number: K232370
    • 23 Jul 2024 Z-3222-2024 Class II Ongoing Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text US Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
      Submission number: K232370
    • 23 Jul 2024 Z-3223-2024 Class II Ongoing Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text US Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
      Submission number: K232370

Frequently asked questions

How many devices does Karl Storz Endoscopy have in the registry?

The registry currently lists 35 devices for Karl Storz Endoscopy. Devices recorded under merged duplicate company entries are counted once.

Which registries list Karl Storz Endoscopy's devices?

Among its 35 most recently registered devices, Karl Storz Endoscopy has devices listed in FDA 510(k) (35 devices).

What risk classes do Karl Storz Endoscopy's devices fall under?

Among its 35 most recently registered devices, the classes recorded for Karl Storz Endoscopy's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Karl Storz Endoscopy?

FDA recall records list 72 recalls initiated by Karl Storz Endoscopy, the most recent initiated on 2026-08-12. 65 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Karl Storz Endoscopy in the registry?

The most recently registered devices listed for Karl Storz Endoscopy include KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS, KSEA QUADRO SWITCH, AUTOCON II 200 ELECTROSURGICAL GENERATOR and KSEA PLASTIC TROCARS.

Generated automatically from registry data and not verified by a human reviewer.