Facility

CIVCO Medical Instruments Co., Inc.

11 recall(s) on record — most severe on record: Class II.

Key facts

11recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1937223
Establishment type	Repack or Relabel Medical Device
Location	750 Lois Lane Coralville, IA, US 52241
Registration status	Active · expires 2026
Parent company	CIVCO Medical Instruments Co., Inc. (owner-operator 1937223)

Activity by year

Recalls (11)
Inspections (1)

Devices registered here (1)

Sterilant, Medical Devices
Product code MED (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6885

Recalls & enforcement

Class IIOngoing2026-03-02
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.
Class IIOngoing2025-05-01
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.
Class IITerminated2021-10-08
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class IITerminated2018-11-02
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Class IITerminated2018-07-30
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.
Class IITerminated2018-02-23
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Class IITerminated2015-10-21
Sterility of the product cannot be assured.
Class IITerminated2015-02-26
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Class IITerminated2014-08-01
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Class IITerminated2013-10-25
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Class IITerminated2012-05-07
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

FDA inspections (1)

NAI2016-06-30
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by CIVCO Medical Instruments Co., Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CIVCO Medical Instruments Co., Inc. (FEI 1937223) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1937223-civco-medical-instruments-co-inc/

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