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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88906

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

Open FDA event record

Event summary

Timeline bucket
October 08, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Civco Medical Instruments Co. 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

4 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 4

VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Z-0395-2022
Recall number
Z-0395-2022
Initiated
October 08, 2021
Classification
Class II
Status
Terminated
Quantity
52 boxes (5 units/box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Code information

Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

device · product 2 of 4

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

Z-0396-2022
Recall number
Z-0396-2022
Initiated
October 08, 2021
Classification
Class II
Status
Terminated
Quantity
9 boxes (5 units/box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Code information

Part Number 610-1153; UDI 00841436102285; Lot Numbers: A122182, A131167, A131689, A131691, A141823

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

device · product 3 of 4

VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

Z-0397-2022
Recall number
Z-0397-2022
Initiated
October 08, 2021
Classification
Class II
Status
Terminated
Quantity
18 boxes (5 units/box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Code information

Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

device · product 4 of 4

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Z-0398-2022
Recall number
Z-0398-2022
Initiated
October 08, 2021
Classification
Class II
Status
Terminated
Quantity
599 boxes (5 units/box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Code information

Part Number 610-1059; UDI 00841436101882 Lot Numbers: A108295, A111466, A111759, A112392, A113288, A113874, A116720, A118295, A118557, A119369, A120039, A120344, A120567, A120641, A120807, A121367, A121506, A121516, A121866, A122103, A123138, A124555, A125980, A127569, A127842, A129198, A129948, A129949, A129950, A130252, A131213, A131428, A132258, A132471, A133741, A133742, A133823, A134199, A134203, A135587, A135846, A136274, A136787, A137788, A138199, A138307, A138805, A139478, A140029, A140660, A142719, A143236, A144157, A144317, A144992, A145774

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.