FDA (Devices) recall action 85407

Genicon, Inc. recalled 14 products on 2020-06-17

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products: 14
Announced: 2020-06-17
Critical: 0
Units: —

Why these products were recalled

There is potential for the plastic optical tip to become detached from the metal shaft.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–14 of 14

HighFDA (Devices)··2020-06-17
Genicon Natura Cannula Recall Due to Detachable Optical Tip
Genicon, Inc. is recalling Natura Model 210-005-151 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Laparoscopic Scope Recall Due to Detaching Optical Tip
Genicon, Inc. is recalling GENILook Model 200-005-153 laparoscopic scopes because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Medical Device Recalled Due to Detached Optical Tip Risk
Genicon, Inc. is recalling GENILook Model 200-105-152 devices because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Cannula Recalled for Potential Tip Detachment
Genicon, Inc. is recalling GENILook cannulas because the plastic optical tip may detach from the metal shaft. The recall affects 378 boxes distributed in the US and abroad.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon Natura Cannula Recalled Due to Potential Tip Detachment
Genicon, Inc. is recalling Natura Model 210-005-251 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
SevereFDA (Devices)··2020-06-17
Genicon Natura Cannula Recalled for Potential Optical Tip Detachment
Genicon, Inc. is recalling Natura Model 210-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Medical Device Recalled Due to Detachment Risk
Genicon, Inc. is recalling GENILook Model 200-005-152 medical devices because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Medical Device Recalled for Potential Tip Detachment
Genicon, Inc. is recalling GENILook Model 200-105-252 devices because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Cannula Recalled Due to Potential Tip Detachment
Genicon, Inc. is recalling GENILook Model 200-105-151 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon Natura Trocar Handle Recall Due to Detaching Optical Tip
Genicon, Inc. is recalling Natura Model 210-005-152 trocar handles because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
SevereFDA (Devices)··2020-06-17
Genicon Natura Trocar Recall Due to Potential Tip Detachment
Genicon, Inc. is recalling Natura Model 210-005-052 trocars because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
SevereFDA (Devices)··2020-06-17
Genicon Natura Cannula Recall Due to Detachable Optical Tip
Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Cannula Recalled Due to Detaching Optical Tip
Genicon, Inc. is recalling GENILook Model 200-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states
HighFDA (Devices)··2020-06-17
Genicon GENILook Cannula Recalled for Potential Tip Detachment
Genicon, Inc. is recalling GENILook Model 200-005-251 cannulas because the plastic optical tip may detach from the metal shaft.
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.
Category
Distribution
7 states