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.

26–36 of 36

  • ModerateFDA (Devices)·Z-0568-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 257 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0565-2019·2018-12-19

    CIVCO Biopsy Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.

    Product
    CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0566-2019·2018-12-19

    CIVCO Recalls SonoSite Needle Guide Brackets Due to Labeling Defects

    CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units lack required product labeling.

    Product
    SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2946-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 107 units of CIVCO Needle Guides because the assembly may lack sufficient adhesive to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2947-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2888-2018·2018-08-29

    Civco Infiniti Needle Guide Bracket Recalled for Leak Testing Failure

    Civco Medical Instruments is recalling Infiniti Needle Guide Brackets because a cover failed leak testing during validation of new needle guides.

    Product
    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 with a tool for performing needle-guided (or catheter) proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2016·2015-11-25

    Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0290-2016·2015-11-25

    Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides

    Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2016·2015-11-25

    Civco Needle Guide Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2016·2015-11-25

    Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2016·2015-11-25

    Civco PercuNav Tracking Bracket Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.

    Product
    CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound t
    Category
    Medical Device
    Distribution
    Distributed nationwide