The FDA has posted 9 enforcement recalls from Civco Medical Instruments Co. Inc. since 2025, none of them Class I (most serious). Most recent report: Apr 8, 2026.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
Firm name as filed with the FDA: “Civco Medical Instruments Co. Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.