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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (tip detachment) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Genicon, Inc. is recalling 10 units of the GENILook Model 200-005-251, 5mm diameter, 150mm length cannula. The product consists of one cannula with a threaded design and a universal handle that can be used as a pistol grip or a traditional trocar handle. The recall involves Lot I9613-A, distributed in two boxes containing five units each.
The recall is being conducted because there is a potential for the plastic optical tip to become detached from the metal shaft. This defect could compromise the integrity of the device during use.
The affected units were distributed to consignees in the United States (Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee) and in foreign countries including Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand. Users should stop using the affected devices and contact Genicon, Inc. for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Genicon, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot I9613-A
Distribution
Part of a larger recall action
This product is one of 14 recalled by Genicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Genicon, Inc.
See all →- HighGenicon Li-Gator Laparoscopic Clip Applier Recalled for Malfunction
FDA (Devices) · 2020-11-11
- HighGenicon Aquas PowerFlow Tube Set Recalled for Lack of FDA Clearance
FDA (Devices) · 2020-10-21
- HighGenicon GENILook Cannula Recalled for Potential Tip Detachment
FDA (Devices) · 2020-06-17
- HighGenicon GENILook Cannula Recalled Due to Detaching Optical Tip
FDA (Devices) · 2020-06-17
- HighGenicon Natura Trocar Handle Recall Due to Detaching Optical Tip
FDA (Devices) · 2020-06-17
Same hazard · structural defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25