The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2269-2020·Announced 2020-06-17

Genicon GENILook Cannula Recalled for Potential Tip Detachment

Genicon, Inc. is recalling GENILook Model 200-005-251 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 involves a medical device with a structural defect (tip detachment) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Genicon, Inc. is recalling 10 units of the GENILook Model 200-005-251, 5mm diameter, 150mm length cannula. The product consists of one cannula with a threaded design and a universal handle that can be used as a pistol grip or a traditional trocar handle. The recall involves Lot I9613-A, distributed in two boxes containing five units each.

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 compromise the integrity of the device during use.

The affected units were distributed to consignees in the United States (Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee) 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 200-005-251, 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.
Category
Medical Device — Surgical Instruments
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 I9613-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 →

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