CLASS II ONGOING Device recall · Reported 11 Nov 2020 · FDA Enforcement Report
A Li-Gator Single Use Laparoscopic Clip Applier recalled by Genicon
Genicon is recalling A Li-Gator Single Use Laparoscopic Clip Applier, distributed nationwide in the US. The recall was initiated on 17 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0310-2021
- FDA event ID
- 86412
- Recalling firm
- Genicon, Winter Park, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2020
- FDA classified
- 30 Oct 2020
- Reported
- 11 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 17 Sep 2020 | Recall initiated by company | |
| 30 Oct 2020 | Classified by FDA | +43 days |
| 11 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device malfunction causing the applier to jam, and clip loading failures.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is A Li-Gator Single Use Laparoscopic Clip Applier recalled?
Yes. Genicon recalled A Li-Gator Single Use Laparoscopic Clip Applier on 17 Sep 2020. The recall is Class II and its status is Ongoing. Recall number Z-0310-2021.
Why was it recalled?
Device malfunction causing the applier to jam, and clip loading failures.
Which lots are affected?
Model # 360-010-001 (A Li-Gator) lot codes: I8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115-A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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