Civco Medical Instruments recalls
Civco Medical Instruments appears in 45 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 45 |
|---|---|
| Published | 2012-07-18 to 2026-04-08 |
| By agency | FDA Device (45) |
| By classification | Class II (45) |
| By status | terminated (36), ongoing (9) |
| Distribution named in notices | AZ, CA, GA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, PA, SD, TN, US, VA, WA, WI |
Recalls
- eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
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. - BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound tra…
FDA Device · Class II · 2025-06-11 · Civco Medical Instruments
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. - VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments
Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. - VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments
Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. - VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments
Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. - VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments
Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. - 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…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - 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…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona,…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments
Reason: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. - CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSi…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments
Reason: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. - SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transduce…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05,…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments
Reason: The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. - CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) nee…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - 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…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - 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 1…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) nee…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
FDA Device · Class II · 2018-09-05 · Civco Medical Instruments
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. - CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
FDA Device · Class II · 2018-09-05 · Civco Medical Instruments
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. - CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound trans…
FDA Device · Class II · 2018-08-29 · Civco Medical Instruments
Reason: A cover failed leak testing during validation testing of new needle guides from a replacement tool. - CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx…
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments
Reason: Sterility of the product cannot be assured. - CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments
Reason: Sterility of the product cannot be assured. - CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 67…
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments
Reason: Sterility of the product cannot be assured. - CIVCO Sales Demo Kit
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments
Reason: Sterility of the product cannot be assured. - CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 1100190…
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments
Reason: Sterility of the product cannot be assured. - CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 61…
FDA Device · Class II · 2015-04-15 · Civco Medical Instruments
Reason: Leaks were detected in the recalled lot which may compromise the sterility of the product. - CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes
FDA Device · Class II · 2014-09-03 · Civco Medical Instruments
Reason: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. - Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box
FDA Device · Class II · 2014-01-29 · Civco Medical Instruments
Reason: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. - Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box
FDA Device · Class II · 2014-01-29 · Civco Medical Instruments
Reason: Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. - CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref.…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments
Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. - CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments
Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. - CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, tr…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments
Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. - CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, tr…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments
Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. - CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments
Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.