Agency classClass IIOur severity:High FDA (Devices)·Z-2274-2020·Announced 2020-06-17

Genicon Natura Cannula Recall Due to Detachable Optical Tip

Genicon, Inc. is recalling Natura Model 210-005-151 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. The hazard involves a structural defect in a medical device that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where harm has not yet been reported.

Plain-English summary

Genicon, Inc. is recalling 106 boxes (5 units per box) of Natura Model 210-005-151 cannulas. The affected units are 5mm in diameter and 100mm in length, featuring one threaded cannula. The recall covers lots I8081-A, I7914-A, and I8033-A.

The recall was initiated 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 product was distributed to US consignees in Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee. It was also distributed 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. Users should stop using the affected devices and contact the manufacturer for instructions.

The recalled product

Product: Genicon Natura Model 210-005-151; 5mm diameter, 100mm 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.
Category: Medical Device — Surgical Instruments
Hazard: structural-defect
component-detachment

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 (3)

Lots I8081-A
I7914-A
and I8033-A

Distribution

Distributed in 7 states:

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 →

Same manufacturer · Genicon, Inc.

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Same hazard · structural defect