VirtuTRAX Instrument Navigator devices may not tighten properly
Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.
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: This is a risk-of-harm medical device where potential injury has not yet been reported. It is classified as FDA Class II, but without reported hospitalization or injury cases, it does not meet the Severe threshold. The mechanical failure could impact patient safety if the device fails to secure instruments during procedures.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator, 10 17 GA model, a medical instrument navigator. The recall is due to a potential mechanical failure in which the device may not tighten properly onto the instrument to be used, potentially preventing proper securing during medical procedures.
Approximately 599 boxes containing 5 units each have been affected by this recall. The devices have been distributed worldwide, including throughout the United States and internationally to Belgium, Canada, China (Mainland and Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand.
The recalled VirtuTRAX Instrument Navigator devices are identified by Part Number 610-1059, UDI 00841436101882, and specific lot numbers from A108295 to A145774. Customers and healthcare providers should verify lot numbers against the complete list maintained by the FDA and the manufacturer.
The recalled product
- Product
- VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Hazard
- mechanical-failure
- functional-failure
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 (20)
- 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
Distribution
Distributed nationwide across the United States.
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