CLASS II ONGOING Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 recalled
Genicon is recalling Genicon GENILook, distributed in 7 states. The recall was initiated on 21 Aug 2018 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-2271-2020
- FDA event ID
- 85407
- Recalling firm
- Genicon, Winter Park, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2018
- FDA classified
- 5 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 21 Aug 2018 | Recall initiated by company | |
| 5 Jun 2020 | Classified by FDA | +654 days |
| 17 Jun 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
There is potential for the plastic optical tip to become detached from the metal shaft.
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
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Where it was distributed
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
AlabamaDelawareFloridaGeorgiaMissouriNorth CarolinaTennessee
Questions about this recall
Is Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 recalled?
Yes. Genicon recalled Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 on 21 Aug 2018. The recall is Class II and its status is Ongoing. Recall number Z-2271-2020.
Why was it recalled?
There is potential for the plastic optical tip to become detached from the metal shaft.
Which lots are affected?
Lot I7781-C
Where was it sold?
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
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.
More recalls from Genicon
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|---|---|---|---|---|---|
| Device | CLASS II | A Li-Gator Single Use Laparoscopic Clip Applier recalled by Genicon | Genicon | Foreign Material | Nationwide |
| Device | CLASS II | Aquas PowerFlow Tube Set recalled by Genicon | Genicon | Sterility | Nationwide |
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| Device | CLASS II | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two recalled | Genicon | Foreign Material | 7 states |
| Device | CLASS II | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 recalled | Genicon | Foreign Material | 7 states |
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