Agency classClass IIOur severity:High FDA (Devices)·Z-2272-2020·Announced 2020-06-17

Genicon GENILook Cannula Recalled Due to Detaching Optical Tip

Genicon, Inc. is recalling GENILook Model 200-105-251 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. 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 risk-of-harm product where injury has not yet been reported.

Plain-English summary

Genicon, Inc. is recalling 28 boxes (140 units) of GENILook Model 200-105-251 cannulas. The affected lots are I7754-, I7878-C, and I8084-C. The product is a 5mm diameter, 150mm length cannula with a universal handle that can be used as a pistol grip or traditional Trocar handle.

The recall is due to a potential defect where the plastic optical tip may become detached from the metal shaft. This issue could compromise the integrity of the medical device during use.

The affected units 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. Users should stop using the affected devices and contact Genicon, Inc. for instructions on return or replacement.

The recalled product

Product: Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 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.
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 (2)

Lots I7754-
I7878-C and I8084-C

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