Recall archive
5 recalls · page 1 of 1
Reported Nov 11, 2020
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Genicon, Inc.
Matched: Brand — Device malfunction causing the applier to jam, and clip loading failures.
FDA (openFDA device enforcement)
Reported Oct 21, 2020
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Genicon, Inc.
Matched: Brand — The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper…
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Genicon, Inc.
Matched: Brand · Product · Product details — There is potential for the plastic optical tip to become detached from the metal shaft.
13 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2020
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Genicon, Inc.
Matched: Brand · Product · Product details · Reason for recall — Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
FDA (openFDA device enforcement)
Reported Mar 28, 2018
GENICON EZEE Retrieval, sterile, Rx only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Genicon, Inc.
Matched: Brand · Product · Product details — Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
FDA (openFDA device enforcement)
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