Civco VirtuTRAX Instrument Navigator Recall: Device May Not Tighten Properly
Civco Medical Instruments recalls VirtuTRAX Instrument Navigator devices that may not tighten onto instruments, posing a risk of improper use. Affected units include specific lot numbers and part numbers.
Lower-risk recall
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Contact the company
What happened, in plain English
Civco Medical Instruments is recalling Virtu:TRAX Instrument Navigators that might not tighten onto surgical instruments. This could lead to improper use during procedures, potentially causing errors or complications. Read more at govinfonow.com/recall/61701-civco-virtutrax-instrument-navigator-recall-device-may-not-tighten-properly.
Source Summary by GovInfoNow · govinfonow.com/recall/61701-civco-virtutrax-instrument-navigator-recall-device-may-not-tighten-properly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0396-2022
Cite this page
“Civco VirtuTRAX Instrument Navigator Recall: Device May Not Tighten Properly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61701-civco-virtutrax-instrument-navigator-recall-device-may-not-tighten-properly. Based on FDA recall #Z-0396-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0396-2022%22&limit=1).
Why it’s dangerous
The VirtuTRAX device may not tighten onto surgical instruments as intended. This could result in the device becoming loose during procedures, potentially causing improper use or errors in medical operations.
Who’s affected
Surgical teams and medical professionals using the VirtuTRAX Instrument Navigator devices are most at risk. Patients and staff using the recalled models may face complications if the device fails to secure properly.
How to tell if you have this one
Check for part number 610-1153, lot numbers A122182, A131167, A131689, A131691, or A141823. The device is sold under the brand Civco Medical Instruments.
- Brand
Civco Medical Instruments- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0395-2022 | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX; Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178 | 52 boxes (5 units/box) |
| Z-0396-2022 | VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX; Part Number 610-1153; UDI 00841436102285; Lot Numbers: A122182, A131167, A131689, A131691, A141823 | 9 boxes (5 units/box) |
| Z-0397-2022 | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX; Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818 | 18 boxes (5 units/box) |
| Z-0398-2022 | VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX; 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 | 599 boxes (5 units/box) |
What to do — step by step
Check Device Part Number
Look for part number 610-1153 on the device label.
Contact Manufacturer
Reach out to Civco Medical Instruments for further assistance if you have the recalled model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0396-2022 (October 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0396-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.