Agency classClass IIOur severity:High FDA (Devices)·Z-2266-2020·Announced 2020-06-17

Genicon GENILook Cannula Recalled for Potential Tip Detachment

Genicon, Inc. is recalling GENILook cannulas because the plastic optical tip may detach from the metal shaft. The recall affects 378 boxes distributed in the US and abroad.

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 (tip detachment) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Genicon, Inc. is recalling the GENILook Model 200-005-151, a 5mm diameter, 100mm length cannula with a threaded design. The recall involves 378 boxes, containing 5 units per box. The product is a medical device used with a universal handle that can function as a pistol grip or a traditional trocar handle.

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 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 specific lot numbers involved are I7920-F, I7951-F, I7957-F, I7985-F, I7850-F, I7902-F, and I8080-F. Users should stop using the affected devices and contact the manufacturer for instructions.

The recalled product

Product: Genicon GENILook Model 200-005-151, 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 (7)

Lots I7920-F
I7951-F
I7957-F
I7985-F
I7850-F
I7902-F
and I8080-F

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.

See all →

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Same hazard · structural defect