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Genicon

Also registered as GENICON, INC.

Country not established

Genicon is a medical device manufacturer, with 258 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 18 FDA recalls as of 14 Nov 2026.

Devices
258
FDA recalls
180 ongoing since 2021 (17 open in total)
17 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 247
  • FDA 510(k) 11

A device listed in two registries counts in both.

Device classes
  • FDA Class I 158
  • FDA Class II 100
FDA recalls

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Genicon makes

Genicon manufactures single-use laparoscopic access cannulas, endoscopic monopolar and bipolar electrosurgical handpieces/electrodes, tissue extraction bags, and open-surgery ligation clip appliers. Their reusable surgical irrigation/aspiration cannulas and metallic ligation clips are also part of their portfolio. The company also produces irrigation/aspiration tubing sets and reusable non-illuminating cannulas for endoscopic procedures.

Genicon’s devices are regulated under FDA classifications, including Class I and Class II, with submissions recorded in the 510(k) and UDI registries.

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

Catalogue258

Newest first, rows 1-50 of 258

Search and filter all 258 devices
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  • GeniPort 100-105-102 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Natura 210-110-252 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • NanoSurge 520-063-950

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniSurge 533-005-930T

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Natura 210-005-250 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cannula 100-112-201 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cannula 100-110-001 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniPalm 100-005-151 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniSurge 533-005-910T

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Natura 210-105-251 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniLook 200-010-250 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniSurge 533-005-950

    Active Regimes: 510(k) Registry: GUDID Class:II

  • GeniPalm 100-005-150 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniLook 200-012-150 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniPalm 100-005-152 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniSurge FX-533-005-905

    Active Regimes: 510(k) Registry: GUDID Class:II

  • GeniStrong 550-000-008G

    Listed Registry: GUDID Class:II

  • GeniLook 200-105-052 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • NanoPort 100-303-051 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cannula 100-010-001 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cap 100-005-631 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniFlow 700-105-010

    Active Regimes: 510(k) Registry: GUDID Class:II

  • GeniPalm 100-110-151 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniClip Open Applier 330-005-004

    Listed Registry: GUDID Class:I

  • GeniLook 200-005-153 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Simply EZee 550-000-026

    Active Regimes: 510(k) Registry: GUDID Class:II

  • GeniLook 200-005-250 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniSurge 533-005-925T

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Natura 210-115-151 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Aquas Powerflow 720-005-001

    Withdrawn Registry: GUDID Class:II

  • GeniLook 200-110-252 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniClip Open Applier 330-005-005

    Listed Registry: GUDID Class:I

  • GeniClip Applier 350-010-003

    Listed Registry: GUDID Class:I

  • GeniFlow 700-005-010

    Active Regimes: 510(k) Registry: GUDID Class:II

  • BiSurge 628-163-920

    Listed Registry: GUDID Class:I

  • GeniClip Applier 350-010-090

    Listed Registry: GUDID Class:I

  • GeniClip Applier 350-005-000

    Listed Registry: GUDID Class:I

  • Natura 210-112-251 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • SimplyStrong 550-000-011

    Listed Registry: GUDID Class:II

  • GeniLook 200-005-251 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Probe 707-005-045

    Active Regimes: 510(k) Registry: GUDID Class:II

  • GeniLook 200-110-152 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniShield 100-112-191 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniPalm 100-105-051 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniLook 200-010-152 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • GeniPalm 100-005-052 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • EZee Retrieval 550-000-000

    Listed Registry: GUDID Class:II

  • NanoPort 100-003-051 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Probe 707-005-233

    Active Regimes: 510(k) Registry: GUDID Class:II

  • GeniPort 100-005-102 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:I

Rows 1-50 of 258

Showing 1-50 of 258

FDA recalls18

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 18 recalls initiated by Genicon, the earliest on 2017-07-19 and the most recent on 2020-09-17. By recorded status: 17 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, electrical or power and mechanical integrity. 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 15
  • 2019 0
  • 2020 2
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 18 recalls.

  • 2020

    • 17 Sep 2020 Z-0310-2021 Class II Open since 2020 Device malfunction causing the applier to jam, and clip loading failures. Distribution: Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Palestinian, Quatar, Saudi Arabia, Slovenia, South Africa, Switzerland, Tunisia, United Kingdom, and Venezuela.
      Submission number: K030269
    • 25 Aug 2020 Z-0094-2021 Class II Open since 2020 The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k). Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai), JORDAN, KUWAIT, SOUTH AFRICA.

  • 2018

    • 21 Aug 2018 Z-2266-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2267-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2268-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2269-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2270-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2271-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2272-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2273-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
Show all 18 recalls

  • 2018

    • 21 Aug 2018 Z-2274-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2275-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2276-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2277-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2278-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 21 Aug 2018 Z-2279-2020 Class II Open since 2018 There is potential for the plastic optical tip to become detached from the metal shaft. Distribution: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic,…
      Full distribution text US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
      Submission number: K982472
    • 27 Jun 2018 Z-2005-2020 Class II Open since 2018 Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. Distribution: Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
      Submission number: K180579

  • 2017

    • 19 Jul 2017 Z-1076-2018 Class II Terminated Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. Distribution: Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark,…
      Full distribution text Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
      Submission number: K162059

Frequently asked questions

How many devices does Genicon have in the registry?

The registry currently lists 258 devices for Genicon. Devices recorded under merged duplicate company entries are counted once.

Which registries list Genicon's devices?

Among its 50 most recently registered devices, Genicon has devices listed in FDA GUDID (50 devices).

What risk classes do Genicon's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Genicon's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Genicon?

FDA recall records list 18 recalls initiated by Genicon, the most recent initiated on 17 Sep 2020. 17 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 Genicon in the registry?

The most recently registered devices listed for Genicon include GeniPort 100-105-102, Natura 210-110-252, NanoSurge 520-063-950 and GeniSurge 533-005-930T.

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