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.
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 involves a medical device with a potential for component detachment, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Genicon, Inc. is recalling the GENILook Model 200-105-252, a 5mm diameter, 150mm length medical device with a 2-cannula design. The recall is issued because there is a potential for the plastic optical tip to become detached from the metal shaft.
The affected units are identified by Lot I8086-C. The recall involves 0 units in inventory, consisting of 6 boxes with 5 units per box. These devices were distributed to consignees in the United States (AL, DE, FL, GA, MO, NC, TN) 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.
Consumers and healthcare providers should stop using the affected devices and contact Genicon, Inc. for further instructions or a replacement.
The recalled product
- 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.
- 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 I8086-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
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