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.
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 structural defect 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 42 boxes (5 units per box) of GENILook Model 200-005-153 laparoscopic scopes. The affected units are 5mm in diameter and 100mm in length, featuring a three-cannula design with a universal handle that can be used as a pistol grip or a traditional trocar handle. The recall covers specific lots identified as I7779-C and I8144-C.
The recall is being issued 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 products 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 the manufacturer for instructions on return or replacement.
The recalled product
- 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.
- 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)
- Lots I7779-C and I8144-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.
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