Kalona, IA, United States
Civco Medical Instruments Co. Inc. recalls
6 recalls recorded since 2018, most recently on 2 March 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)2
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 March 2026
- Reason
- 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.
- Distribution
- US States: OH, PA, WA. China.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1734-2026, Z-1738-2026, Z-1733-2026, Z-1736-2026, Z-1732-2026, Z-1735-2026, Z-1737-2026, Z-1731-2026
- eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
- eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
- eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
- eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
- eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
- eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
Ongoing Class II Medical devices
- Recall started
- 1 May 2025
- Reason
- 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.
- Distribution
- OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1892-2025
- BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Terminated Class II Medical devices
- Recall started
- 8 October 2021
- Terminated
- 30 September 2024
- Reason
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0396-2022, Z-0395-2022, Z-0398-2022, Z-0397-2022
- VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
- VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
- VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
- VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Terminated Class II Medical devices
- Recall started
- 2 November 2018
- Terminated
- 20 November 2020
- Reason
- Distribution
- Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Rom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0567-2019, Z-0576-2019, Z-0565-2019, Z-0566-2019, Z-0574-2019, Z-0573-2019, Z-0569-2019, Z-0563-2019, Z-0571-2019, Z-0572-2019, Z-0564-2019, Z-0562-2019 and 3 more
- SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
- CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
- CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
- SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
- CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
- CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
- CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 seri
- SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
- and 7 more product lines
Terminated Class II Medical devices
- Recall started
- 30 July 2018
- Terminated
- 16 September 2020
- Reason
- The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
- Distribution
- United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2947-2018, Z-2946-2018
- CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
- CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Terminated Class II Medical devices
- Recall started
- 23 February 2018
- Terminated
- 6 October 2020
- Reason
- A cover failed leak testing during validation testing of new needle guides from a replacement tool.
- Distribution
- Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2888-2018
- CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians w
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.