Recall Register

Civco Medical Instruments Co. Inc.: FDA recalls

FDA enforcement reports name Civco Medical Instruments Co. Inc. as the recalling firm in 7 events. The events have 36 product records. The recalls started from 2015 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of Civco Medical Instruments Co. Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
2 Mar 2026eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149DeviceClass II8Ongoing
1 May 2025BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducersDeviceClass II1Ongoing
8 Oct 2021VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAXDeviceClass II4Terminated
2 Nov 2018CIVCO 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.DeviceClass II15Terminated
30 Jul 2018CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EODeviceClass II2Terminated
23 Feb 2018CIVCO 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) procedures with the use of diagnostic ultrasound…DeviceClass II1Terminated
21 Oct 2015CIVCO 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.DeviceClass II5Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Civco Medical Instruments Co. Inc.: events for each product type
TypeEvents
Device7
Civco Medical Instruments Co. Inc.: events in each class
ClassEvents
Class II7
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Civco Medical Instruments Co. Inc., by the year that the recall started. The largest year is 2018, with 3 events.

Official channels

Cite this page

Recall Register. Civco Medical Instruments Co. Inc.: FDA recalls. https://recallregister.com/firm/civco-medical-instruments-co-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Civco Medical Instruments Co. Inc. have?
Class II: 7 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Civco Medical Instruments Co. Inc.?
FDA event 98513, which the firm started on 2 Mar 2026. The first product in the record is: eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
How many FDA recalls of Civco Medical Instruments Co. Inc. have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.