The Recall Desk

Manufacturer

CIVCO Medical Instruments Co., Inc.

36 recalls in our database name CIVCO Medical Instruments Co., Inc. as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
0
Severe
0
Most recent
2026-04-08

Of the 36 recalls from CIVCO Medical Instruments Co., Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 36

  • HighFDA (Devices)·Z-1734-2026·2026-04-08

    Civco eTRAX 18G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1732-2026·2026-04-08

    Civco eTRAX 14G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1738-2026·2026-04-08

    Civco eTRAX 18G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1736-2026·2026-04-08

    Civco eTRAX 14G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1733-2026·2026-04-08

    Civco eTRAX needle starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1735-2026·2026-04-08

    Civco eTRAX 12G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1731-2026·2026-04-08

    Civco eTRAX 12G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1737-2026·2026-04-08

    Civco eTRAX needle sensor may misreport needle tip position onscreen

    Civco is recalling the eTRAX Needle Sensor 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified on the user interface.

    Product
    eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1892-2025·2025-06-11

    BX2 Needle Guide may develop transducer cover breach during attachment

    Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.

    Product
    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0397-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten Properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator sensors because they may fail to tighten properly onto surgical instruments. This functional defect could affect safe use during medical procedures.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2022·2021-12-29

    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.

    Product
    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

    Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2022·2021-12-29

    VirtuTRAX Instrument Navigator recalled for potential tightening failure

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.

    Product
    VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2019·2018-12-19

    CIVCO Recalls SonoSite L25 Bracket Kits Due to Puncture Risk

    CIVCO Medical Instruments is recalling SonoSite L25 Bracket Kits because the needle guide bracket may puncture the sterile cover during assembly.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0564-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Puncture Risk

    CIVCO is recalling Needle Guide Brackets that may puncture the sterile cover during assembly, potentially compromising sterility.

    Product
    CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0562-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Puncture Risk

    CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they may puncture the sterile cover during assembly.

    Product
    CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0567-2019·2018-12-19

    CIVCO Recalls SonoSite FUJIFILM Needle Guide Brackets for Labeling Issues

    CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.

    Product
    SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0574-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.

    Product
    CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0570-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, 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 series transducers, 22 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0569-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    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 series transducers, 21 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0571-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled Due to Missing Product Labeling

    CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0575-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.

    Product
    CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0572-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0573-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0576-2019·2018-12-19

    CIVCO Sales Demo Kit Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have product labeling.

    Product
    CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
    Category
    Medical Device
    Distribution
    0 states