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Use caution Medical device recall · FDA · Published September 17, 2020

Genicon Li-Gator Laparoscopic Clip Applier Recall: Jamming and Clip Failures

Genicon recalls single-use laparoscopic clip appliers (model 360-010-001) due to jamming and clip loading failures. Affected units sold with specific lot codes.

🇺🇸 FDA recall #Z-0310-2021Medical deviceGenicon ›
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Recalling firmGenicon, Inc.6869 Stapoint Ct Ste 112 · Winter Park, FL 32792-6603
✎ GovInfoNow plain-language explainer

What happened, in plain English

Genicon is recalling single-use laparoscopic clip appliers that can jam or fail to load clips. This could lead to improper surgical procedures if used during medical procedures. Read more at govinfonow.com/recall/64267-genicon-li-gator-laparoscopic-clip-applier-recall-jamming-and-clip.

Source Summary by GovInfoNow · govinfonow.com/recall/64267-genicon-li-gator-laparoscopic-clip-applier-recall-jamming-and-clip · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0310-2021

Cite this page

“Genicon Li-Gator Laparoscopic Clip Applier Recall: Jamming and Clip Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64267-genicon-li-gator-laparoscopic-clip-applier-recall-jamming-and-clip. Based on FDA recall #Z-0310-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2021%22&limit=1).

Why it’s dangerous

The applier may jam during use, causing clips to fail to load properly. This could lead to improper surgical procedures if the clips are not applied correctly.

Who’s affected

Surgical teams using the Genicon Li-Gator clip appliers for procedures involving tubular structures. Patients undergoing surgery with these devices are at risk of improper clip application.

How to tell if you have this one

Check for model number 360-010-001 with lot codes I8250 through I9719-A and J0113-A through J0243-A. These units were sold for use on tubular structures or vessels.

  • Brand
    Genicon
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Recalled Model

    Identify the model number 360-010-001 with specific lot codes listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Indiana, Missouri, Tennessee.

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Sep 17, 202012. FDA classified it Class II: Oct 30, 202023. Published in FDA’s Enforcement Report: Nov 11, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0310-2021 (September 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0310-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA