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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85407

14 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 21, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Genicon, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

14 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 14

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.

Z-2266-2020
Recall number
Z-2266-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
378 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

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

Distribution pattern

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 Thailand

device · product 2 of 14

Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Z-2267-2020
Recall number
Z-2267-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
48 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I7717-C

Distribution pattern

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 Thailand

device · product 3 of 14

Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Z-2268-2020
Recall number
Z-2268-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
42 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lots I7779-C and I8144-C

Distribution pattern

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 Thailand

device · product 4 of 14

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.

Z-2269-2020
Recall number
Z-2269-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
2 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I9613-A

Distribution pattern

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 Thailand

device · product 5 of 14

Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Z-2270-2020
Recall number
Z-2270-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
74 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lots I7718-D, I7780-D, and I8068-D

Distribution pattern

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 Thailand

device · product 6 of 14

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.

Z-2271-2020
Recall number
Z-2271-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
12 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I7781-C

Distribution pattern

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 Thailand

device · product 7 of 14

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.

Z-2272-2020
Recall number
Z-2272-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
28 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lots I7754-, I7878-C and I8084-C

Distribution pattern

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 Thailand

device · product 8 of 14

Genicon Natura Model 210-005-051; 5mm diameter, 70mm 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.

Z-2273-2020
Recall number
Z-2273-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
3 box (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I8003-A (nonsterile samples made for sales)

Distribution pattern

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 Thailand

device · product 9 of 14

Genicon Natura Model 210-005-151; 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.

Z-2274-2020
Recall number
Z-2274-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
106 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lots I8081-A, I7914-A, and I8033-A

Distribution pattern

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 Thailand

device · product 10 of 14

Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Z-2275-2020
Recall number
Z-2275-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
102 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lots I7968-A, I8182-A

Distribution pattern

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 Thailand

device · product 11 of 14

Genicon Natura Model 210-005-251, 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.

Z-2276-2020
Recall number
Z-2276-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
10 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I8880-A

Distribution pattern

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 Thailand

device · product 12 of 14

Genicon Natura Model 210-105-251, 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.

Z-2277-2020
Recall number
Z-2277-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
17 boxes (5 units per box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lots I7931-A and I8069-A

Distribution pattern

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 Thailand

device · product 13 of 14

Genicon GENILook Model 200-105-252, 5mm diameter, 150mm 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.

Z-2278-2020
Recall number
Z-2278-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
0 (6 boxes with 5 units/per box in inventory)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I8086-C

Distribution pattern

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 Thailand

device · product 14 of 14

Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Z-2279-2020
Recall number
Z-2279-2020
Initiated
August 21, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
0 (24 boxes with 5 units/box in inventory)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for the plastic optical tip to become detached from the metal shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for the plastic optical tip to become detached from the metal shaft.

Code information

Lot I9524-A

Distribution pattern

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 Thailand