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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a potential component detachment in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Genicon, Inc. is recalling 12 boxes (5 units per box) of GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) devices. The recall is due to a potential defect where the plastic optical tip may become detached from the metal shaft.
The affected devices were distributed to US consignees in Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee, as well as 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. The specific lot number is I7781-C.
Consumers and healthcare providers should stop using the affected devices immediately and contact Genicon, Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Genicon, Inc.
- Hazard
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 I7781-C
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 · component detachment
See all →- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Potential Ceramic Tip Detachment
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- ModerateGalt Medical Recalls Boston Scientific Transcarotid Access Kits
FDA (Devices) · 2026-08-19
Similar recalls
- HighGenicon EZEE Retrieval recalled due to plastic handle breaking off shaft
FDA (Devices) · 2018-03-28
- HighGenicon Li-Gator Laparoscopic Clip Applier Recalled for Malfunction
FDA (Devices) · 2020-11-11
- HighMedtronic Disposable Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-10-26
- HighMedtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits
FDA (Devices) · 2016-10-26
- SevereOptikon Bipolar Pencil surgical tool recalled for tube failure risk
FDA (Devices) · 2024-12-25
- SevereOlympus Guide Sheath Kits recalled for potential radiopaque tip detachment
FDA (Devices) · 2025-02-19