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.
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 structural defect (detaching tip) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Genicon, Inc. is recalling the Natura Model 210-005-152, a 5mm diameter, 100mm length trocar handle with two cannulas. The recall involves 102 boxes, containing 5 units per box, distributed to consignees in the United States and several foreign countries. The affected lots are I7968-A and I8182-A.
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 pose a risk during medical procedures where the handle is used with a scope.
Healthcare providers and consumers who possess these specific units should stop using them immediately and contact Genicon, Inc. for instructions on return or replacement. The product was distributed to consignees in Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee, as well as to 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 recalled product
- 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.
- 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 (2)
- Lots I7968-A
- I8182-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.
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