Severity
Moderate
FDA Devices recall · Reported June 17, 2020
There is potential for the plastic optical tip to become detached from the metal shaft.
Genicon, Inc. recalled Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - … - a moderate-severity action.
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - … was recalled by Genicon, Inc. in June 17, 2020. Reason: There is potential for the plastic optical tip to become detached from the metal shaft.. Check the official notice for the remedy. Verify recall #Z-2266-2020 with the FDA Devices before acting.
The recall
Genicon, Inc. issued this moderate-severity FDA Devices recall-There is potential for the plastic optical tip to become detached from the metal shaft..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2266-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2266-2020) was formally reported on June 17, 2020, with the manufacturer initiating the action on August 21, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Genicon, Inc. is listed as the recalling firm, operating out of Winter Park, FL. Federal records list the affected scope as 378 boxes (5 units per box).
The documented reason for this recall is: There is potential for the plastic optical tip to become detached from the metal shaft. Distribution data in the federal record shows the product reached: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Afric…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
378 boxes (5 units per box)
Related Recalls
6
3 from same agency
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.
There is potential for the plastic optical tip to become detached from the metal shaft.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2266-2020 |
| Date reported | June 17, 2020 |
| Date initiated | August 21, 2018 |
| Recalling firm | Genicon, Inc. |
| Firm location | Winter Park, FL |
| Affected scope | 378 boxes (5 units per box) |
| Distribution | US consignees in AL, DE, FL, GA, MO, NC, TN 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 17, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.