Genicon, Inc.: There is potential for the plastic optical tip to become detached from the metal shaft.

Agency Publication Date: June 5, 2020

Affected Products

Product: Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I7754-, I7878-C and I8084-C

Product: Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lot I8003-A (nonsterile samples made for sales)

Lot Numbers:

I8003-A

Product: Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I8081-A, I7914-A, and I8033-A

Product: Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I7968-A, I8182-A

Product: Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lot I8880-A

Lot Numbers:

I8880-A

Product: Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I7931-A and I8069-A

Product: Genicon GENILook Model 200-105-252, 5mm diameter, 150mm 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.

Lot I8086-C

Lot Numbers:

I8086-C

Product: Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lot I9524-A

Lot Numbers:

I9524-A

Product: Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lot I9613-A

Lot Numbers:

I9613-A

Product: Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I7718-D, I7780-D, and I8068-D

Product: 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.

Lot I7781-C

Lot Numbers:

I7781-C

Product: Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I7779-C and I8144-C

Product: Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lot I7717-C

Lot Numbers:

I7717-C

Product: Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Lots I7920-F, I7951-F, I7957-F, I7985-F, I7850-F, I7902-F, and I8080-F

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85407

Status: Active

Manufacturer: Genicon, Inc.

Manufactured In: United States

Units Affected: 14 products (378 boxes (5 units per box); 48 boxes (5 units per box); 42 boxes (5 units per box); 2 boxes (5 units per box); 74 boxes (5 units per box); 12 boxes (5 units per box); 28 boxes (5 units per box); 3 box (5 units per box); 106 boxes (5 units per box); 102 boxes (5 units per box); 10 boxes (5 units per box); 17 boxes (5 units per box); 0 (6 boxes with 5 units/per box in inventory); 0 (24 boxes with 5 units/box in inventory))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lots I7754-, I7878-C and I8084-C

Lot I8003-A (nonsterile samples made for sales)

Lot Numbers:

I8003-A

Lots I8081-A, I7914-A, and I8033-A

Lots I7968-A, I8182-A

Lot I8880-A

Lot Numbers:

I8880-A

Lots I7931-A and I8069-A

Lot I8086-C

Lot Numbers:

I8086-C

Lot I9524-A

Lot Numbers:

I9524-A

Lot I9613-A

Lot Numbers:

I9613-A

Lots I7718-D, I7780-D, and I8068-D

Lot I7781-C

Lot Numbers:

I7781-C

Lots I7779-C and I8144-C

Lot I7717-C

Lot Numbers:

I7717-C

Lots I7920-F, I7951-F, I7957-F, I7985-F, I7850-F, I7902-F, and I8080-F

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85407

Status: Active

Manufacturer: Genicon, Inc.

Manufactured In: United States