Genicon Natura Cannula Recalled Due to Potential Tip Detachment
Genicon, Inc. is recalling Natura Model 210-005-251 cannulas 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 involves a risk-of-harm product (medical device) where the hazard is potential tip detachment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Genicon, Inc. is recalling 10 boxes (5 units per box) of Natura Model 210-005-251 cannulas, 5mm diameter, 150mm length. The product is a threaded cannula with a universal handle that can be used as a pistol grip or like a traditional Trocar handle when using a scope.
The recall is being issued because there is potential for the plastic optical tip to become detached from the metal shaft. This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed to US consignees in Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee. Foreign consignees included 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 I8880-A. Users should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Genicon Natura Model 210-005-251, 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.
- 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 I8880-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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