Winter Park, FL, United States
Genicon, Inc. recalls
5 recalls recorded since 2018, most recently on 17 September 2020. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 September 2020
- Reason
- 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 of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0310-2021
- A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended
Ongoing Class II Medical devices
- Recall started
- 25 August 2020
- Reason
- 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, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai), JORDAN, KUWAIT, SOUTH AFRICA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0094-2021
- Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
Ongoing Class II Medical devices
- Recall started
- 21 August 2018
- Reason
- 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, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2267-2020, Z-2275-2020, Z-2270-2020, Z-2266-2020, Z-2277-2020, Z-2268-2020, Z-2273-2020, Z-2276-2020, Z-2274-2020, Z-2278-2020, Z-2272-2020, Z-2271-2020 and 2 more
- Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 27 June 2018
- Reason
- 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 Denmark.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2005-2020
- Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Terminated Class II Medical devices
- Recall started
- 19 July 2017
- Terminated
- 18 May 2020
- Reason
- 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, Spain, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1076-2018
- GENICON EZEE Retrieval, sterile, Rx only.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.