Genicon Li-Gator Laparoscopic Clip Applier Recalled for Malfunction
Genicon, Inc. is recalling 8,872 Li-Gator Single Use Laparoscopic Clip Appliers due to device malfunction causing the applier to jam and clip loading failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device malfunction (jamming and loading failures) which poses a risk of harm during a surgical procedure, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Genicon, Inc. is recalling 8,872 units of the Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm (Model # 360-010-001). The recall is due to device malfunction causing the applier to jam and clip loading failures. The product is intended for use on tubular structures or vessels wherever a metal ligating clip is intended.
The affected devices were distributed worldwide, including nationwide distribution in the United States and in specific states such as Florida, Tennessee, Missouri, California, Georgia, and Indiana. International distribution includes countries such as Chile, Croatia, France, Germany, and the United Kingdom. Specific lot codes are listed in the official recall notice.
Healthcare providers and facilities should stop using the affected devices and contact Genicon, Inc. for instructions on return or replacement. Patients who have had the device used should consult their healthcare provider if they have concerns regarding the procedure.
The recalled product
- Product
- 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
- Manufacturer
- Genicon, Inc.
- Affected units
- 8,872
Distribution
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