The Recall Desk
HighFDA (Devices)·Z-2271-2020·Announced 2020-06-17

Genicon GENILook Medical Device Recalled Due to Detached Optical Tip Risk

Genicon, Inc. is recalling GENILook Model 200-105-152 devices because the plastic optical tip may detach from the metal shaft.

What this means for you

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 the hazard involves a potential component detachment in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Genicon, Inc. is recalling 12 boxes (5 units per box) of GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) devices. The recall is due to a potential defect where the plastic optical tip may become detached from the metal shaft.

The affected devices were distributed to US consignees in Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee, as well as 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 number is I7781-C.

Consumers and healthcare providers should stop using the affected devices immediately and contact Genicon, Inc. for further instructions or a replacement.

The recalled product

Product
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 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

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 I7781-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 →

Related recalls

Same manufacturer · Genicon, Inc.

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Same hazard · component detachment

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